Floridamd april 2016

APRIL 2016 • COVERING THE I-4 CORRIDOR

UF Health Cancer Center – Orlando Health High-Volume Head and Neck Cancer Center Gives Patients Best Chances for Prolonged Quality of Life

New Name, New Team

NEW SPECIALTIES Head & Neck Surgery Center of Florida is now Florida ENT Surgical Specialists J. Scott Magnuson, MD and Florida ENT Surgical Specialists are proud to introduce two new world-class members of our medical team.

J. Scott Magnuson, MD

Michael D. Seidman, MD

Board Certified in Otolaryngology/Head and Neck Cancer Surgery

Board Certified in Otolaryngology and Neurotologic Surgery

Bruce Haughey, MD Board Certified in Otolaryngology/Head and Neck Cancer Surgery

ADVANCED SURGICAL OPTIONS AND SPECIALTIES • Complex Head and Neck Cancers

• Skin Cancer

• Acoustic Neuromas

• Airway, Voice and

• Cochlear Implants

• Sleep Apnea

• Ear and Skull Base Tumors

• Pediatric ENT Issues

COMING •UP NEXTTumors MONTH: The cover storyProblems will be about the proton therapy program available at Benign Swallowing • Semi- and Fully-Implantable The Proton Center at UF Health Cancer Center – Orlando Health.

Editorial focus is on Cancer • Thyroid Disorders • Complex Ear Disorders Hearing Implants and Dermatology

410 Celebration Pl., Ste. 305, Celebration, FL 34747 407.303.4120 office | 407.303.4124 fax

FloridaENTSpecialists.com 16-FHMG-01529

contents 4

APRIL 2016 COVERING THE I-4 CORRIDOR

 COVER STORY

PHOTO: DONALD RAUHOFER / FLORIDA MD

UF Health Cancer Center – Orlando Health, Head and Neck Cancer Center has the advanced cancer-fighting, life-enhancing capabilities that come with being a specialized, high-volume facility.

“Head and neck cancers are serious and often life changing,” says Kavita M. Pattani, M.D., F.A.C.S., medical director for Head and Neck Surgical Oncology. “The anatomy of the head and neck is complex, and the cancers can be associated with substantial morbidity. UF Health Cancer Center – Orlando Health offers the expertise to properly target the source of the cancer and provide individualized treatment planning that addresses all the patient will need, including, but not limited to, the cosmetic aspect.”

25 MEDICAL OFFICE RESOURCES OF FLORIDA IS MORE OF WHAT HEALTHCARE NEEDS 26 CRITICAL CONDITION: DOCTOR GROUPS LINK ARMS TO SAVE PROFESSION --FED UP WITH EXCESSIVE OVERSITE, DOCTORS GET ORGANIZED – PART TWO 27 THE HIPAA PRIVACY RULE

PHOTO: PROVIDED BY ORLANDO HEALTH

ON THE COVER: Kavita M. Pattani, M.D. Medical Director Head & Neck Surgical Oncology UF Health Cancer Center at Orlando Health

DEPARTMENTS 2

FROM THE PUBLISHER

3

HEALTHCARE LAW

9

HEALTHCARE BANKING, FINANCE AND WEALTH

10 PULMONARY & SLEEP DISORDERS 15 MARKETING YOUR PRACTICE 17 ORTHOPAEDIC UPDATE 18 CANCER 20 DIGESTIVE AND LIVER UPDATE 22 BEHAVIORAL HEALTH 24 INPATIENT REHABILITATION

FLORIDA MD - APRIL 2016 1

FROM THE PUBLISHER

I

am pleased to bring you another issue of Florida MD. Over the years, I’ve expressed my genuine appreciation of the medical community within Central Florida. I’ve engaged with countless brilliant physicians and medical-related professionals who are great at their trade and, perhaps more importantly, great people as well.

Many of these fine individuals are so dedicated to providing care to patients that they not only serve those at their practice, but also many other patients in need at free and charitable clinics, including Shepherd’s Hope. As a reminder, this faith-based medical nonprofit organization provides local primary and secondary practitioners with a powerful platform to provide care to those who are uninsured or underinsured. Do you have just one evening to spare per month?

Best regards, Donald B. Rauhofer Publisher

COMING NEXT MONTH: The cover story focuses on Alexander Rosemurgy, MD and the Digestive Health Institute at Florida Hospital Tampa. Editorial focus is on Women’s Health and Advances in Cosmetic Surgery.

SHARE YOUR HOPE AT A FREE CLINIC IN CENTRAL FLORIDA A Doctor’s Invitation to Give Back When Dr. Christopher Crotty was asked 19 years ago by his pastor, William S. Barnes, at St. Luke’s United Methodist, to volunteer at a newly-launched free clinic for the uninsured, he said, “why would you need a dermatologist at a free clinic? No one will need a skin specialist.”

That couldn’t have been farther from the truth. On February 14, 1997, the first Shepherd’s Hope clinic opened. It was miraculous, but even more amazing was the first patient who came in had cervical cancer, was referred for treatment, was cured, and returned as a volunteer. The next three had dermatological issues, and Dr. Crotty was there to provide them care.

“I know why I was needed that night and continue to be needed today” says Crotty. “There isn’t a night when someone doesn’t need hope that they will be “OK”. Because they wait so long to get medical care due to lack of financial resources and insurance, their conditions are often exasperated.”

Dr. Crotty reaffirms that he knew instinctively he “was called” and encourages each of us to say yes! The need is great even after three years of full implementation of the Affordable Care Act. Nearly 1-in-4 Central Floridians, or 448,000, are uninsured today.

Last year, 16,300 free patient visits and medical services were provided at five health centers in Central Florida, 221,000 since 1997.

An all-volunteer medical staff and innovative partnerships between multiple faiths, hospitals, diagnostic partners and teams of volunteers—2,200 total last year — makes it possible.

By operating under the Volunteer Healthcare Provider Programthrough Florida’s Department of Health and the Florida S.S. 766.28Sovereign Immunity Law, an essential safety measure is in placeprotecting licensed medical providers.

Say “YES” to volunteering at Shepherd’s Hope or to accepting referrals for patients in your office. The rewards are meaningful. You will give hope to many, and you may just find your own hope along the way.

For information, call (407) 876-6699 ext. 225 or emailVolunteer@ShepherdsHope.org.

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PREMIUM REPRINTS

For more information on advertising in Florida MD, call Publisher Donald Rauhofer at (407) 417-7400, fax (407) 977-7773 or info@floridamd www.floridamd.com

Reprints of cover articles or feature stories in Florida MD are ideal for promoting your company, practice, services and medical products. Increase your brand exposure with high quality, 4-color reprints to use as brochure inserts, promotional flyers, direct mail pieces, and trade show handouts. Call Florida MD for printing estimates.

Email press releases and all other related information to: info@floridamd.com

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Publisher: Donald Rauhofer Photographer: Donald Rauhofer / Florida MD Contributing Writers: Heidi Ketler, Sajid Hafeez, MD, Daniel T. Layish, MD, Srinivas Seela, MD, Julie Tyk, Esq., Elizabeth Feldman, MS, DMD, Jeff Holt, Marni Jameson, Michelle Bilsky, Kristy Bautista-Harris, MS, Anita White, Dorothy Mowbray, Corey Gehrold Art Director/Designer: Ana Espinosa Florida MD is published by Sea Notes Media,LLC, P.O. Box 621856, Oviedo, FL 32762. Call (407) 417-7400 for more information.

Advertising rates upon request. Postmaster: Please send notices on Form 3579 to P.O. Box 621856, Oviedo, FL 32762.

Although every precaution is taken to ensure accuracy of published materials, Florida MD cannot be held responsible for opinions expressed or facts expressed by its authors. Copyright 2012, Sea Notes Media. All rights reserved. Reproduction in whole or in part without written permission is prohibited. Annual subscription rate $45.

HEALTHCARE LAW

Opioid Prescriptions: Recent Convictions

By Julie A. Tyk, Esq. Deaths from drug overdoses have exploded around the country.

Every day, more than 40 Americans die from overdoses of opioid painkillers, according to the Center for Disease Control and Prevention (CDC), and each year, 2 million people abuse or misuse the drugs. Many state lawmakers have responded to the crisis by introducing bills to restrict prescribing. To combat the nation’s deadly prescription painkiller epidemic the CDC recently published the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings.

The CDC Guideline is available at http://www.cdc.gov/mmwr/ volumes/65/rr/rr6501e1.htm.

to distribute oxycodone, which carries a maximum sentence of 20 years in prison, and two counts of unlawful distribution of oxycodone, which carries a maximum sentence of 20 years in prison each. Between October 2012 and December 2014, Dr. Mirilasvihil wrote more than 13,000 medically unnecessary prescriptions for oxycodone.

He collected more than $2.4 million in fees for office visits during this time period. Dr. Mirilasvihil is scheduled to be sentenced on July 20, 2016.

Prosecutors around the country are cracking down on physicians for their prescribing practices. Below are some examples of recent convictions of physicians prescribing opioid medications to patients.

The prosecution of doctors is still rare, and murder charges rarer still, when treatment of patients results in injury or death. However, the line between committing a crime and medical malpractice is becoming more and more unclear and depends largely on how reckless and egregious the prosecutors consider the misconduct to be.

On February 24, 2016, Dr. Edward Neil Feldman, an orthopedist, in Pinellas Park, Florida was convicted of illegally prescribing oxycodone and other substances that led to the deaths of three patients, Joey Mayes, 24, Ricky Gonzalez, 42, and Shannon Wren, 42. Dr. Feldman’s wife was convicted along with her husband on five related counts, including conspiring to dispense controlled substances for no legitimate medical purpose outside the usual course of professional practice and money laundering, in a $5.7 million drug and money conspiracy. U.S. District Judge James D. Whittenmore ordered both Feldmans into custody and scheduled sentencing for May 23, 2016. Dr. Feldman faces life in prison.

On February 5, 2016, Hsui-Yoing “Lisa” Tseng, a general practitioner, in Los Angeles, California was sentenced to 30 years to life for the deaths of Vu Nguyen, 28, Steven Ogle, 24, and Joseph Rovero III, 21. On October 30, 2015, Tseng was convicted of three counts of second-degree murder, 19 counts of unlawful controlled substance prescription and one count of obtaining a controlled substance by fraud. Tseng barely kept any records on the three patients until she was contacted by the Medical Board of California, prosecutors said. Then she fabricated documents to make it look like she had kept thorough records. The painkillers Tseng prescribed included oxycodone and hydrocodone. Tseng ignored pleas from family members of the patients who demanded she stop prescribing them drugs, prosecutors said. Her conviction marks the first time in the United States that a doctor was convicted of murder for overdose deaths of three patients given prescription drugs.

The Health Law Team here at GrayRobinson is committed to assisting clients in navigating all areas of practice. Please feel free to contact us at your convenience.

Julie A. Tyk, JD, is an attorney in the Health Care Practice and Litigation Practice Groups with GrayRobinson, P.A. Julie concentrates her practice in peer review, medical malpractice, transportation litigation and insurance defense. She has represented physicians, hospitals, ambulatory surgical centers, nurses and other health care providers across the state of Florida.

She may be contacted by calling (407) 244-5694; julie.tyk@ gray-robinson.com or by visiting www.gray-robinson.com. 

On February 19, 2016, Dr. William Crittenden, III was convicted in the U.S. District Court in Baltimore of conspiring to distribute oxycodone and alprazolam and eight counts of unlawfully distributing oxycodone.

On March 17, 2016, Dr. Moshe Mirilasvihil was convicted in the Southern District of New York of one count of conspiracy FLORIDA MD - APRIL 2016 3

COVER STORY

UF Health Cancer Center – Orlando Health

High-Volume Head and Neck Cancer Center Gives Patients Best Chances for Prolonged Quality of Life

By Heidi Ketler so patients do not get frustrated, and ensures the proper treatment is happening in an ideal fashion,” Dr. Pattani says. “This is further enhanced by the role of our nurse navigator.”

The closely networked, multidisciplinary program allows for effective communication and response should a patient’s condition change. “If surgery is no longer an option because of a newly identified comorbidity; if the chemoradiation the patient is getting is not working; if there is functional decline, it’s easy for the team to communicate this information amongst each other.

Because we’re all in constant communication and all in the same location, we can quickly modify treatment plans along the way.”

“The Head and Neck Cancer Center also offers a variety of services to community practices, which helps to reinforce a strong working relationship,” says Dr. Pattani. “For example, we work closely with community medical oncologists, radiation oncologists, and a variety of specialists. This allows for us to extend our services and facility and collaborate with our colleagues.”

Early diagnosis and specialized treatment increases the likelihood of a cure for a potentially aggressive disease process. “When caught in its early stages, we can decrease the morbidities, as well as the mortality, associated with head and neck cancers. For those patients whose cancers are loDr. Pattani has detailed discussions with patients regarding risks, alternatives, and benefits of surgery. cally advanced or have metastaThe etiology, disease process and surgeries are thoroughly discussed to the patients’ full understanding. sized, treatment (at UF Health Cancer Center – Orlando Health) focuses on prolonging and improving quality of life,” says Dr. Pattani.

UF Health Cancer Center – Orlando Health, Head and Neck Cancer Center has the advanced cancer-fighting, life-enhancing capabilities that come with being a specialized, high-volume facility.

“Head and neck cancers are serious and often life changing,” says Kavita M. Pattani, M.D., F.A.C.S., medical director for Head and Neck Surgical Oncology. “The anatomy of the head and neck is complex, and the cancers can be associated with substantial morbidity. UF Health Cancer Center – Orlando Health offers the expertise to properly target the source of the cancer and provide individualized treatment planning that addresses all the patient will need, including, but not limited to, the cosmetic aspect.”

UF Health Cancer Center – Orlando Health, Head and Neck Cancer Center is unique, as a high-volume center in central Florida that has a full-service, multidisciplinary program under one roof, according to Dr. Pattani. “Other regional programs don’t share these volumes, and their services may not be as comprehensive or centrally located.”

Centralized services make the logistics much easier on patients and their families. “Our network of services provides good flow,

HEAD AND NECK CANCERS: TYPES, INCIDENCE, PROGNOSIS

PHOTO: DONALD RAUHOFER / FLORIDA MD

The head and neck region is an anatomically diverse and complex area of the body, with soft tissue, bones, skin and a variety of glands and organs. Cancers of the head and neck encompass a wide range of tumors that can develop in several areas, including salivary glands, nose, nasal passages, and sinuses. Skin cancers and endocrine tumors/ cancers pertaining to the head and neck also are encountered in large volumes.

4 FLORIDA MD - APRIL 2016

According to the American Cancer Society Cancer Facts & Figures 2016, an estimated 61,760 people (45,330 men and 16,430 women) are expected to develop one of these cancers in the United States in 2016, and 13,190 are expected to die from it.

Risk factors for head and neck cancers include: tobacco use, heavy alcohol consumption, prolonged sun exposure and certain viruses, including human papillomavirus (HPV) and Epstein-Barr virus. The overall incidence of HPV-positive head and neck cancers is rapidly increasing in the U.S., as HPV-negative cancer is decreasing.

HPV-related head and neck cancer is clinically and biologically distinct from tobacco-related (HPV-negative). The tumor that is HPV-positive has a favorable prognosis and reConstant communication with team members is necessary within and between the disciplines in order to ensure appropriate treatment planning and provide high quality care. In particular, the sponds better to the available modalinurse navigator is extremely important in overseeing coordination and timeliness. ties of radiation, chemotherapy and surgery. many sites, they remain poor in others, according to Dr. Pattani.

An estimated 48,330 new cases of oropharyngeal cancer, and “There is mounting evidence in clinical trials that patients may 9,570 deaths are expected in 2016. Most of these tumors are lobenefit from targeted molecular therapy and immunotherapy. cated on the base of the tongue and tonsil region and may be Our center offers a large variety of ongoing clinical trials, and found incidentally during a routine dental or physical examinapatients are screened appropriately,” she says. tion. While a strong relationship has been established between Patients cured of HNSCC have an approximate 10 percent risk HPV Type 16 and the development of oropharyngeal cancer, of developing another primary cancer of the head and neck at five other HPV types have been associated with oropharyngeal cancer years after treatment. “Therefore, we encourage annual screening as well. exams to be done for our patients and five years of close follow “Now that HPV is a known entity, we are able to stratify paup.” tients better,” says Dr. Pattani. “When we do that we are able Thyroid cancer also is treated at the Head and Neck Center. It to potentially adjust treatment for: 1) nonresponders and those is diagnosed in an estimated 37,000 people each year in the U.S., who respond less, such as smokers, as opposed to those who reaffecting women nearly three times more often than men. Unspond very well; and 2) in those respective groups based on their like many cancers that are more common in older adults, thyroid responses, how do we continue to improve survival and quality cancer occurs mainly between the ages of 10 and 55. of life?”

Most thyroid nodules are benign, and most thyroid cancer is There are numerous trials nationally that are assessing changes curable.

Approximately 97 percent of patients with thyroid canin the delivery and intensity of the different modalities and the cer survive at least five years beyond diagnosis. Changes in the consequences.

DNA of cells play a role in the development of thyroid cancer, Most types of head and neck cancer begin in the moist, squathough the exact cause is unclear. mous cells of the mouth, nose and throat. Head and neck squa“Our practice deals with a high volume of complex thyroid dismous cell carcinoma (HNSCC) is estimated to cause 5 percent ease and offers surgery and multidisciplinary planning for benign of all cancers in the U.S. and malignant disease,” says Dr. Pattani.

Early-stage HNSCC is treated relatively well with single-modality therapy (either surgery or radiation alone). However, a large percentage of patients present with advanced disease (Stage III-IV).

For those with advanced HNSCC, traditional management has consisted of multiple-modality therapy with surgery, radiation and chemotherapy. While medical progress has greatly improved long-term survival rates, functional outcomes and toxicities for

Parathyroid cancer is rare and frequently misdiagnosed. Only about 100 cases are diagnosed each year. A strong indication of cancer of the parathyroid gland is the production of extremely high amounts of parathyroid hormone and blood calcium levels.

Parathyroid cancer has no preventable risk factors.

“More often we encounter parathyroid masses that are benign but are still causing high levels of parathyroid hormone and calFLORIDA MD - APRIL 2016

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PHOTO: DONALD RAUHOFER / FLORIDA MD:

COVER STORY

PHOTO: PROVIDED BY ORLANDO HEALTH

COVER STORY

Complicated surgeries are performed very efficiently and safely in a fully equipped OR setting with highly trained staff participating at a high volume center. The center provides a full compliment of service lines in order to collaborate if and when necessary.

cium levels. Our facility provides state-of-the-art imaging to localize these glands. These patients are offered surgical resection as well.”

DEDICATED, COMPREHENSIVE SERVICES The head and neck cancer specialists at UF Health Cancer Center – Orlando Health are recognized for their comprehensive, multidisciplinary approach to improving survival and quality of life for patients.

A full complement of head and neck cancer services offers state-of-the-art technology and innovative therapy.

Clinical trials Dental oncology – medical oncology and nuclear medicine services Nutrition services Oral and maxillofacial surgery Otolaryngology Palliative care Pathology Patient educational services Physical therapy Plastic and reconstructive surgery Psychosocial services Radiation oncology Radiology Surgical oncology Social services: support groups and speech and swallowing therapy “Patients are referred to us by a variety of sources. Often refer6 FLORIDA MD - APRIL 2016

ring physicians will send patients to us for further workup. The patient may already have a diagnosis of cancer, but the staging or the exact target area may not be known,” Dr. Pattani says.

The diagnostic and treatment process for head and neck cancer patients is typically overseen at UF Health Cancer Center – Orlando Health by the surgical oncology team in concert with the multidisciplinary medical team. It begins with proper diagnosis and staging and involves physical examination and evaluation of a number of tests, including endoscopy, imaging scans and biopsy.

A range of diagnostics at the Cancer Center includes: Biopsy* Bone scan Calcitonin blood test to check for medullary thyroid cancer Chest X-ray Computed tomography (CT) Endoscopy HPV testing Image-guided biopsy Labwork Laryngoscopy Magnetic resonance imaging (MRI) Molecular testing Octreotide and technetium scans Positron emission tomography (PET)/CT SPECT (single-photon emission computed tomography) Radioactive Iodine Whole body scan Swallow/dysphagia evaluation, using the modified barium swallow (MBS) test

COVER STORY Stroboscopy – Endoscopy performed with an intermittent light at a frequency approximating that of the movement of the visualized object, giving the object a motionless appearance. This is useful in analyzing vocal-fold structure and motion.

Thyroid scan Transnasal esophagoscopy* TSH blood test for thyroid function Ultrasound X-ray/barium swallow *Procedure may be provided in-office.

When testing is complete, cases are presented at the weekly head and neck tumor conference.

MULTIDISCIPLINARY COLLABORATION Treatment planning at the Head and Neck Cancer Center is a collaborative process among fellowship-trained specialists, who include surgical, medical and radiation oncologists. Evaluation and planning extends across multiple disciplines to include plastic and reconstructive surgeons, dental oncologists, speech therapists, nutritionists and rehabilitation therapists, among other highly trained clinicians and staff.

“The multidisciplinary conference is a forum where we meet weekly in order to have a consensus on treatment planning,” says Dr. Pattani. Tumor conference specialists “make sure they agree on the diagnosis from the pathology that is reported. They also make sure the imaging is apropos, and the patient’s nutritional status is up, speech and swallowing has been addressed, smoking cessation is under way and psychosocial support is initiated,” says Dr. Pattani.

The individual cases reviewed each week include new and post-op patients. After resection, cases are reviewed again, and the treatment plan is adjusted accordingly. “Does what we found change anything? Do we move forward with radiation or chemoradiation or do we stay the course?” says Dr. Pattani of the thought process involved.

“Our first goal is to remove the cancer and treat it. Our second goal is to preserve functionality, trying to get as close to (the patient’s speaking and swallowing) baseline as we can. The third goal is to provide desirable cosmetic results,” says Dr. Pattani.

Treatment depends on the tumor location and stage, the patient’s age and overall health. For many patients, a combination of radiation therapy, surgery and chemotherapy provides effective results, says Dr. Pattani. New investigational treatments also may be recommended.

“It’s not a black-and-white, one-size-fits-all scenario. We have multiple modalities that all work, but are influenced by a variety of variables. That’s why the multidisciplinary tumor conference is important,” says Dr. Pattani. “We discuss why the patient may benefit from a certain modality over another.”

Throughout the process, the patient and family are informed of tumor board recommendations and rationale, the possible side effects or complications and the expected benefits. Patients have multiple meetings with the team members to help clarify the plan

and make sure the patient is well informed.

STATE-OF-THE-ART SURGICAL TECHNIQUES Surgery is used to diagnose, stage and treat cancer and to manage certain cancer-related symptoms. Improvements in surgical techniques better enable surgeons today to remove tumors while preserving nearby structures involved in sensory and physical functioning.

“For the last several years we have been performing neck dissections to remove lymph nodes while sparing the sternocleidomastoid muscle, the spinal accessory nerve and the internal jugular vein. This helps to decrease significant morbidity. New technologies also allow for improved exposure and less-invasive techniques,” says Dr. Pattani. For example, minimally invasive endoscopic laser surgery removes tumors in the larynx and pharynx with minimal impact on speech and swallowing.

Complex surgery to remove tumors at the base of the skull – in the past considered nearly impossible – can now be safely performed. These rare skull-base procedures are performed in collaboration with the neurosurgery and plastic and reconstructive teams at Orlando Health, according to Dr. Pattani.

Robotic surgery is used for difficult-to-reach places within the confines of the head and neck. “Imagine the morbidity that used to be involved in difficult, open surgeries to remove tumors in the back of the tonsils or the tongue,” says Dr. Pattani, alluding to the incision in the neck and the need to split the jaw. “The robot gives the surgeon 3-D and magnified visualization and the agility to negotiate the difficult nooks and crannies without maximally invasive techniques for the patient.”

Patients who undergo extensive surgery for head or neck cancers typically require reconstruction of the areas impacted to restore function, such as eating and speaking, and appearance. Microvascular reconstruction of complicated three-dimensional structures is a mainstay. UF Health Cancer Center – Orlando Health plastic and reconstructive surgeons are one of the only groups in central Florida providing these services in high volumes, according to Dr. Pattani.

Complex reconstruction of bones and soft tissue may also be necessary. For example, in cases where the jaw bone must be removed, the reconstructive surgeon creates a new jaw using part of a bone in the patient’s own leg. Similarly, skin and muscle from a patient’s thigh, arm, or leg is used to replace gaps in the face, scalp, neck, oral cavity (tongue and mouth) and throat. Dental and maxillofacial surgeons use implants to replace teeth lost during treatment.

“We also provide prosthetic structures for people undergoing major surgery on the nose or ears,” Dr. Pattani says.

Traditional and minimally invasive surgeries include: Botulism toxin injection to treat muscle spasms, excessive glandular secretions, and cosmesis* Endoscopic laser surgery Head and neck cancer resection and reconstruction Laryngeal surgery Laryngectomy FLORIDA MD - APRIL 2016

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COVER STORY Lymph node removal/neck dissection Microvascular reconstruction of the head and neck Minimally invasive anterior-skull-base surgery Minimally invasive video-assisted thyroidectomy Oral cavity tumor resection Parathyroid surgery Parotid surgery for salivary gland tumors Pharyngectomy Sinus surgery Skin cancer excision (including lymph node mapping) Thyroid surgery, including revision Tracheotomy/tracheostomy Transoral laser microsurgery Transoral robotic surgery *Procedure may be provided in-office.

On initial encounter by the surgical oncologist it is determined if the patient needs consultation with medical oncology, radiation oncology, or other specialized disciplines. If so these appointments are made at the same time. After surgery, patients are referred for radiation or chemoradiation or both depending on repeated pathology review. “This helps ensure comprehensive treatment for the patient with ongoing and continuous assessment,” says Dr. Pattani.

In addition to chemotherapy, state-of-the-art treatments include: Brachytherapy Immunotherapy Intensity-modulated radiotherapy (IMRT) Proton therapy Trials involving chemotherapy agents Novel molecular targeting agents also are available.

PROMISING NEW TREATMENTS The Head and Neck Cancer Center is incorporating into its cancer-fighting arsenal novel therapies that are paving the way for more personalized, effective treatment.

“There are lots of permutations of treatment modalities that we offer that have been in clinical trials and are in the news right now,” such as molecular targeting, says Dr. Pattani. A number of targeted agents have been approved or are under investigation to treat such head and neck cancers as squamous cell carcinoma.

Unlike conventional modalities (surgery, radiation, chemotherapy), which damage normal tissue, molecular targeted therapies selectively kill cancer cells with little or no effect on the normal cells of the body. “Treatment using molecular targets can supplement or replace some of the intensive chemotherapy that is used,” says Dr. Pattani.

With increasing understanding of the molecular biology of HNSCC, molecular pathways may be modified, enabling cancer therapy at the molecular level. Some of the new therapeutic approaches inhibit tumor growth and metastasis by targeting the tumor microenvironment or vasculature or focusing on specific protein or signal transduction pathways.

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The Cancer Genome Atlas offers a comprehensive analysis of 279 somatic mutations of HNSCC, enhancing the opportunities for identifying therapeutic targets. Emerging insights into distinct genetic and biologic characteristics, such as the genetic differences between HPV-positive and HPV-negative head and neck cancer, may eventually guide treatment choices.

“While currently HPV status does not influence treatment choices, increasingly clinical trials are exploring whether HPVpositive tumors may require less therapy, thus potentially reducing long-term side effects in a younger patient population,” says Dr. Pattani.

The latest news is the early discontinuation of the Phase III CheckMate-141 trial when anti-PD-1 agent nivolumab met its primary endpoint of overall survival improvements in patients with platinum-refractory HNSCC. It raises hopes of immunosuppression of cancer and stimulation of the immune system as a fourth therapeutic modality.

EARLY DETECTION IS BEST CHANCE FOR CURE “We need to increase awareness on the importance of early detection, when the cancers are still treatable, with good cure rates,” says Dr. Pattani.

“We see a lot of Stage 3 and 4 cancers here. It’s not unusual for a patient to have thought they had allergies or chronic sinusitis, when all that time they had sinus cancer. There’s not a lot that you can do to curtail that, since 99.9 percent of the population will have allergies at some point.”

Currently there is no annual screening for head and neck cancers, “so it’s up to the primary points of contact – primary care providers, obstetrician/gynecologists and dentists – to be on the lookout for symptoms.”

Dr. Pattani recommends visiting one’s primary care physician or dentist for a yearly examination of the head, neck and oropharynx. If symptoms related to these areas persist for four to six weeks despite antibiotics, they may need evaluation by a head and neck specialist: Chronic sinusitis Neck mass Sticking sensation in the throat Hoarseness or a change in voice with no obvious cause “Watching and waiting is not the ideal scenario,” says Dr. Pattani. “New patients at UF Health – Orlando Health can be seen in days rather than months.”

For more information or to schedule an appointment call (321) 841-7171. 

HEALTHCARE BANKING, FINANCE AND WEALTH

How to Reduce Chances of Theft in Your Medical Practice – Healthcare practices are one of the most common sites of embezzlement

By Jeff Holt, CMPE, VP, Senior Healthcare Business Banker with PNC Bank As an owner or manager of a medical practice today there are so many areas needing your attention, which can draw focus away from properly dealing with elements at risk for financial loss. After reviewing the revenue cycle of many medical practices over the past ten years I recognize that the overlooking of these “at risk” areas have been growing. One of the primary growing areas of risk for financial loss is employee theft (embezzlement).

Your staff members are essential to the smooth functioning of your practice, and you rely on them to keep things going. But according to a 2014 report by the Association of Certified Fraud Examiners (ACFE), healthcare businesses are likely to be victims of fraud, with yearly losses averaging $175,000 per practice. The same study also found that small businesses are disproportionately affected — and under protected — from fraud and employee theft.[1] Three major types of employee theft plague healthcare practices, according to the Medical Group Management Association.[2] Here are the top three ways employees steal, along with tips for preventing them: • Removing cash from the daily deposit.

If your practice accepts cash for copayments and other charges, an employee could take some of this cash and hope not to be detected. Warning signs that this might be happening generally come in the form of patient complaints when they’re being billed for something they’ve already paid for. You can help prevent this type of theft by blocking staff access to any means that could allow them to delete accounts, appointment records or payments.

It may also help if the person accepting the cash payments isn’t the same person who fields patient complaints. Consider using software that records and reconciles payments, as well as video surveillance.

• Paying personal bills from company funds.

Giving your employees access to checks and/or credit cards from your practice puts you at risk for internal theft. To help prevent this, you or a third-party firm should regularly examine outgoing funds, including credit card statements, bank statements and check records.[3] • Falsifying payroll records.

The person in charge of your payroll can adjust hours and/or pay rates beyond what you’ve authorized. Per the ACFE, this is generally the longest-lasting form of fraud, which means it has the potential to do great harm to your practice. It also occurs almost twice as often in small businesses as large ones.[4]

Your best protection is keeping a close eye on things. Personally review payroll payments regularly — and let your workers know this is part of your practice. The best way to combat fraud and employee theft is to prevent it before it happens.

Finally, think about who are your key partners (internally and externally) that you depend on each day to protect the interests of the practice in this area, and how accountable and dependable they are in doing so. Those partners are essential to help with reducing risks associated with embezzlement.

Important Legal Disclosures and Information: 1. http://www.acfe.com/rttn/docs/2014-report-to-nations.pdf 2. http://www.mgma.com/practice-resources/articles/mgmaconnexion/2010/case-studies-mgma-employee-theft-andembezzlement-research 3. ibid.

4. http://www.acfe.com/rttn/docs/2014-report-to-nations.pdf The third-party trademarks referenced in these articles are owned by and are the registered trademarks of their respective third-party owners. There is no affiliation, sponsorship or endorsement relationship between PNC or its affiliates and any such third party.

PNC is a registered mark of The PNC Financial Services Group, Inc. (‘‘PNC’’) The information in this article is not intended as legal, tax or accounting advice or as recommendations to engage in any specific transaction, including with respect to any securities of PNC, and do not purport to be comprehensive. Under no circumstances should any information contained in the presentation, the webinar or the materials presented be used or considered as an offer or commitment, or a solicitation of an offer or commitment, to participate in any particular transaction or strategy or should it be considered legal advice. Any reliance upon any such information is solely and exclusively at your own risk. Please consult your own counsel, accountant or other advisor regarding your specific situation.

Neither PNC Bank nor any other subsidiary of The PNC Financial Services Group, Inc. will be responsible for any consequences of reliance upon any opinion or statement contained here, or any omission. The opinions expressed in these materials or videos are not necessarily the opinions of PNC Bank or any of its affiliates, directors, officers or employees. Banking and lending products and services, bank deposit products, and Treasury Management products and services for healthcare providers and payers are provided by PNC Bank, National Association, a wholly owned subsidiary of PNC and Member FDIC. Lending and leasing products and services, including card services and merchant services, as well as certain other banking products and services, may require credit approval.

Jeff Holt is a Senior Healthcare Business Banker and V.P. with PNC Bank’s Healthcare Business Banking and is a Certified Medical Practice Executive. He can be reached at (352) 385-3800 or Jeffrey.Holt@pnc.com.

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FLORIDA MD - APRIL 2016

9

PULMONARY AND SLEEP DISORDERS

Update on the Paradigm for Treating Pulmonary Arterial Hypertension: Significance of the AMBITION Trial By Daniel T. Layish, MD, FACP, FCCP, FAASM Without pharmacologic therapy, WHO Group I pulmonary arterial hypertension (PAH) is a progressive fatal illness. (Table 1).

There are three main pathways involved in the pathophysiology of PAH which currently offer treatment options. (Figure 1) These TABLE I: WORLD HEALTH ORGANIZATION CLASSIFICATION OF PULMONARY HYPERTENSION (2013 Nomenclature) WHO Group 1: Pulmonary arterial hypertension (PAH). a) Idiopathic. b) Genetic PAH. c) Drug and toxin induced PAH. d) PAH associated with connective tissue diseases, HIV infection, portal hypertension, congenital heart disease with right to left shunting, schistosomiasis WHO Group 2: Pulmonary venous hypertension: this can be seen in the setting of left ventricular systolic or diastolic dysfunction or valvular heart disease or left ventricular outflow tract obstruction WHO Group 3 Pulmonary Hypertension: This includes pulmonary hypertension secondary to hypoxia as can be seen in COPD, interstitial lung disease, sleep-disordered breathing, alveolar hypoventilation or chronic exposure to high altitude WHO Group 4 Pulmonary Hypertension: Chronic thromboembolic pulmonary hypertension, this occurs with chronic pulmonary emboli which do not resolve and lead to a mechanical obstruction; this is the only surgically curable form of pulmonary hypertension so it is critical to exclude WHO Group 5: Pulmonary hypertension secondary to miscellaneous disorders such as chronic hemolytic anemia, sarcoidosis and glycogen storage disease

include the endothelin, nitric oxide and prostacyclin pathways.

Activation of the nitric oxide pathway leads to vasodilation and inhibition of cell proliferation. Endothelin receptor antagonists (ERA) inhibit the endothelin receptor, resulting in vasodilation and inhibition of vascular smooth muscle cell proliferation. Phosphodiesterase type 5 inhibitors (PDE-5i) augment the nitric oxide pathway by disrupting the breakdown of cyclic GMP. The prostacyclin pathway leads to vasodilation and inhibition of vascular smooth muscle proliferation. The first PAH-specific therapy was epoprostenol (Flolan®), which was approved by the FDA in 1995, but requires an indwelling catheter and a continuous intravenous infusion. Since 1995, there have been several approvals of other pharmacologic therapies for the treatment of PAH. Oral therapy was introduced when bosentan (Tracleer®), an ERA, was approved by the FDA in 2001. The second ERA approved by the FDA was ambrisentan (Letairis®) in 2007. There are two currently available PDE-5 inhibitors, sildenafil (Revatio®) and tadalafil (Adcirca®), approved by the 10 FLORIDA MD - APRIL 2016

FDA in 2005 and 2009, respectively.

Traditionally, when patients progressed despite treatment with either an ERA or a PDE-5i, sequential combination therapy was offered. However, some of the combinations studied did not seem to result in an additive benefit. In addition, drug interactions can be problematic. For example, bosentan lowers the availability of sildenafil which may reduce the efficacy of this therapy, while sildenafil raises the availability of bosentan which may increase the risk of hepatotoxicity.

The rationale for the AMBITION trial was to determine if early aggressive therapy with two drugs targeting different pathways is more efficacious than monotherapy. It was a prospective, randomized, double-blind, multicenter study designed to evaluate safety and efficacy of upfront combination therapy with ambrisentan plus tadalafil versus ambrisentan or tadalafil alone in treatment naive patients with WHO Group I PAH. Overall, 500 patients were randomized 2:1:1 to receive either upfront combination therapy with ambrisentan and tadalafil (N=253) or monotherapy with ambrisentan (N=126) or tadalafil (N=121). Ambrisentan was titrated from 5 mg up to 10 mg once a day over an 8 week period, and tadalafil was titrated from 20 mg to 40 mg once a day over 4 weeks. The primary end point was time to first clinical failure event, which was a composite end point, incorporating both the traditional components of clinical worsening Figure 1

PULMONARY AND SLEEP DISORDERS (death, hospitalization and disease progression) with a component of unsatisfactory long-term clinical response. Upfront combination therapy with ambrisentan and tadalafil reduced the risk of clinical failure by 50% compared to monotherapy with ambrisentan or tadalafil. The study was not designed to compare ambrisentan versus tadalafil alone. The treatment effect for the composite primary end point of time to clinical failure was mainly driven by a reduced number of hospitalizations related to PAH. The risk of hospitalization due to PAH was reduced by 63% in the group which received upfront combination therapy. The reduction in clinical failure events were seen regardless of the etiology of PAH, WHO functional class, age, or gender. There were also improvements in the secondary end points including N-terminal pro-B-type natriuretic peptide and six minute walk distance. Overall the combination therapy was well tolerated.

Side effects were similar to that seen with monotherapy including peripheral edema, headache, and nasal congestion.

The results of the AMBITION trial have been received enthusiastically by pulmonary hypertension specialists and seem to confirm the hypothesis that upfront combination therapy targeted at more than one of the pathophysiologic pathways is beneficial. However, these results should not be extrapolated to other combinations, which were either not studied or were studied and did not show beneficial effects. The treatment algorithms for PAH continue to be rapidly evolving. For example, the recent approval of riociguat (Adempas®), macitentan (Opsumit®) as well as oral treprostinil (Orenitram®) and the oral prostacyclin receptor agonist selexipag (UpHealthSouth Rehabilitation travi®). The pace of new drug development Hospital of Altamonte Springs has really been fairly miraculous since epoOffers a Higher Level of Care. prostenol was initially approved in 1995. It is certainly exciting to have more treatment options to offer our patients with this lifeOur patients and families hear a lot about a threatening illness. However, much work higher level of care. What does this mean still needs to be done to understand the speto you? Our rehabilitation teams work with cific role of various combination therapies. patients and their families, providing superior Nevertheless, the AMBITION study is care with quality outcomes to return patients truly a landmark trial in our understanding to maximum independence at home and in of the optimal treatment strategy for PAH. the community.

HERE’S HOW.

Daniel Layish, MD, graduated magna cum laude from Boston University Medical School in 1990. He then completed an Internal Medicine Residency at Barnes Hospital (Washington University) in St.Louis, Missouri and a Pulmonary/Critical Care/ Sleep Medicine Fellowship at Duke University in Durham, North Carolina. Since 1997, he has been a member of the Central Florida Pulmonary Group in Orlando. He serves as Co-

To a patient recovering from an illness, injury or surgery, a higher level of care means: • Personalized goals for a faster return home • Comprehensive team approach to rehabilitative care • Advanced technologies for the latest treatments • Frequent physician* visits • Three hours of therapy over a day, five days a week • 24-hour certified rehabilitation nursing care Choose a rehabilitation leader that makes a difference for patients and families with a higher level of care. HealthSouth Rehabilitation Hospital of Altamonte Springs. *The hospital provides access to independent physicians

A Higher Level of Care®

director of the Adult Cystic Fibrosis Program in Orlando. He may be contacted at 407-841-1100 or by visiting www.cfpulmonary.com.

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831 South State Road 434 • Altamonte Springs, FL 32714 407 587-8600 healthsouthaltamontesprings.com ©2016:HealthSouth Corporation:452913

FLORIDA MD - APRIL 2016 11

Start with AMBITION Letairis + tadalafil initial combination therapy

Letairis + tadalafil is approved for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to: • Reduce the risk of disease progression • Reduce the risk of hospitalization for worsening PAH • Improve exercise ability The study establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (58%) or PAH associated with connective tissue diseases (36%).2

Start Letairis + tadalafil and learn more about the AMBITION trial at www.AMBITIONcombination.com

Start with

AMBITION

Important Safety Information BOXED WARNING: EMBRYO-FETAL TOXICITY • Do not administer Letairis to a pregnant female because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals • Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment • Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program

Please see Brief Summary of full Prescribing Information, including BOXED WARNING, on following pages.

12 FLORIDA MD - APRIL 2016

Important Safety Information (continued) Contraindications • Pregnancy: Letairis can cause fetal harm • Idiopathic Pulmonary Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO Group 3) Warnings and Precautions • Embryo-fetal toxicity and Letairis REMS Program requirements: – Prescribers must be certified with the program by enrolling in and completing training – All female patients, regardless of reproductive potential, must enroll in the Letairis REMS Program – Male patients are not enrolled in the program – Pharmacies must be certified with the program and must dispense to female patients who are authorized to receive Letairis Further information is available at www.letairisrems.com or 1-866-664-5327.

• Peripheral edema: Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH. Further evaluate patients who develop clinically significant fluid retention to determine the cause and possible need for edema treatment or to discontinue Letairis. In clinical studies, peripheral edema was more common with Letairis than with placebo (most edema was mild to moderate in severity); and with Letairis plus tadalafil than with either drug alone. There have also been postmarketing reports of fluid retention occurring within weeks after starting Letairis that required a diuretic, fluid management, or hospitalization for decompensating heart failure • Pulmonary edema with pulmonary veno-occlusive disease (PVOD): Consider PVOD in patients who develop acute pulmonary edema during Letairis initiation and discontinue Letairis if PVOD is confirmed • Decreased sperm counts have been observed in patients taking endothelin receptor antagonists and in animal fertility studies with ambrisentan. Counsel patients about potential effects on fertility • Hematologic changes: Measure hemoglobin prior to initiation of Letairis, at 1 month, and periodically thereafter.

Letairis initiation is not recommended for patients with clinically significant anemia. Consider discontinuing Letairis if clinically significant decreases in hemoglobin occur and other causes have been excluded. Decreases in hemoglobin and hematocrit have been observed within the first few weeks of Letairis treatment, which may persist during treatment. There have also been postmarketing reports of anemia requiring transfusion Adverse Reactions • Most common adverse reactions in combination with tadalafil compared to Letairis or tadalafil monotherapy were peripheral edema (45% vs 38% or 28%), headache (41% vs 34% or 35%), nasal congestion (19% vs 16% or 11%), cough (18% vs 13% or 16%), anemia (15% vs 7% or 11%), dyspepsia (11% vs 3% or 12%), and bronchitis (10% vs 4% or 9%) Drug Interactions • Cyclosporine increases ambrisentan exposure by 2-fold, limit Letairis to 5 mg once daily Use in Specific Populations • Breastfeeding: Choose Letairis or breastfeeding • Hepatic impairment: Letairis is not recommended in patients with moderate or severe hepatic impairment.

Fully investigate cause of liver injury in patients who develop hepatic impairment; discontinue Letairis if liver aminotransferases are >5x ULN or if elevations are accompanied by bilirubin >2x ULN, or by signs or symptoms of liver dysfunction and other causes are excluded Dosage and Administration • Adult dosage: Initiate Letairis 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, consider either increasing to Letairis 10 mg or tadalafil 40 mg. Do not split, crush, or chew tablets • Pregnancy testing: Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment

Please see Brief Summary of full Prescribing Information, including BOXED WARNING, on following pages.

References: 1. Letairis [Prescribing Information]. Foster City, CA: Gilead Sciences, Inc.; October 2015. 2. Data on file. Gilead Sciences, Inc. FLORIDA MD - APRIL 2016 13

Letairis (ambrisentan) tablets, for oral use Brief summary of full Prescribing Information.

See full Prescribing Information. Rx only.

WARNING: EMBRYO-FETAL TOXICITY Do not administer Letairis to a pregnant female because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals [see Contraindications, Warnings and Precautions, Use in Specific Populations].

Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and one month after discontinuation of treatment [see Dosage and Administration, Use in Special Populations].

Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program [see Warnings and Precautions].

INDICATIONS AND USAGE: Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening; and in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).

DOSAGE AND ADMINISTRATION: See Contraindications, Warnings and Precautions, and Use in Specific Populations for additional information.

Adult Dosage: Initiate treatment at 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, either increase Letairis to 10 mg or tadalafil to 40 mg, as needed and tolerated. Do not split, crush, or chew tablets.

Pregnancy Testing in Females of Reproductive Potential: Initiate treatment with Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment [see Contraindications, Warnings and Precautions, Use in Specific Populations].

CONTRAINDICATIONS: Pregnancy: Letairis may cause fetal harm when administered to a pregnant female.

Letairis was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see Warnings and Precautions, Use in Specific Populations]. Idiopathic Pulmonary Fibrosis: Letairis is contraindicated in patients with Idiopathic Pulmonary Fibrosis (IPF) including IPF patients with pulmonary hypertension (WHO Group 3).

WARNINGS AND PRECAUTIONS: Embryo-fetal Toxicity and Letairis REMS Program: For all females, Letairis is available only through a restricted program called the Letairis REMS, because of risk of embryo-fetal toxicity [see Contraindications, Warnings and Precautions, Use in Specific Populations]. Notable requirements of the Letairis REMS program include that the Prescribers must be certified with the program by enrolling and completing training. All females, regardless of reproductive potential, must enroll in the Letairis REMS program prior to initiating Letairis. Male patients are not enrolled in the REMS. Females of reproductive potential must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations]. Pharmacies that dispense Letairis must be certified with the program and must dispense to female patients who are authorized to receive Letairis. Further information is available at www.letairisrems.com or 1-866-664-5327.

Fluid Retention: Peripheral edema is a known class effect of endothelin receptor antagonists (ERAs), and is also a clinical consequence of PAH and worsening PAH. In the placebo-controlled studies, there was an increased incidence of peripheral edema in patients treated with doses of 5 or 10 mg Letairis compared to placebo [see Adverse Reactions]. Most edema was mild to moderate in severity, and it occurred with greater frequency and severity in elderly patients. In addition, there have been postmarketing reports of fluid retention in patients with pulmonary hypertension, occurring within weeks after starting Letairis. Patients required intervention with a diuretic, fluid management, or, in some cases, hospitalization for decompensating heart failure. If clinically significant fluid retention develops, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as Letairis or underlying heart failure, and the possible need for specific treatment or discontinuation of Letairis therapy. Peripheral edema/fluid retention is more common with Letairis plus tadalafil than with Letairis or tadalafil alone. Pulmonary Veno-occlusive Disease: If patients develop acute pulmonary edema during initiation of therapy with vasodilating agents such as Letairis, the possibility of pulmonary veno-occlusive disease should be considered, and if confirmed Letairis should be discontinued.

Decreased Sperm Counts: Decreased sperm counts have been observed in human and animal studies with another ERA and in animal fertility studies with ambrisentan. Letairis may have an adverse effect on spermatogenesis. Counsel patients about potential effects on fertility [see Specific Populations]. Hematological Changes: Decreases in hemoglobin concentration and hematocrit have followed administration of other ERAs and were observed in clinical studies with Letairis. These decreases were observed within the first few weeks of treatment with Letairis, and stabilized thereafter. The mean decrease in hemoglobin from baseline to end of treatment for those patients receiving Letairis in the 12-week placebo-controlled studies was 0.8 g/dL. Marked decreases in hemoglobin (>15% decrease from baseline resulting in a value below the lower limit of normal) were observed in 7% of all patients receiving Letairis (and 10% of patients receiving 10 mg) compared to 4% of patients receiving placebo. The cause of the decrease in hemoglobin is unknown, but it does not appear to result from hemorrhage or hemolysis. In the long-term open-label extension of the two pivotal clinical studies, mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin concentrations persisted for up to 4 years of treatment. There have been postmarketing reports of decreases in hemoglobin concentration and hematocrit that have resulted in anemia requiring transfusion. Measure hemoglobin prior to initiation of Letairis, at one month, and periodically thereafter. Initiation of Letairis therapy is not recommended for patients with clinically significant anemia. If a clinically significant decrease in hemoglobin is observed and other causes have been excluded, consider discontinuing Letairis.

ADVERSE REACTIONS: See BOXED WARNING and Warnings and Precautions for additional serious adverse reactions. Clinical Trials Experience: Safety data for Letairis are presented from two 12-week, placebocontrolled studies (ARIES-1 and ARIES-2) in patients with PAH, and one randomized, double-blind, activecontrolled trial in 605 patients with PAH (AMBITION) comparing Letairis plus tadalafil to Letairis or tadalafil alone. The exposure to Letairis in these studies ranged from 1 day to 4 years (N=357 for at least 6 months and N=279 for at least 1 year). Use in monotherapy: In ARIES-1 and ARIES-2, a total of 261 patients received Letairis at doses of 2.5, 5, or 10 mg once daily and 132 patients received placebo. The adverse reactions that

14 FLORIDA MD - APRIL 2016

occurred in >3% more patients receiving Letairis than receiving placebo are shown in Table 1.

Table 1 Adverse Reactions with Placebo-Adjusted Rates >3% Placebo (N=132) LETAIRIS (N=261) Adverse reaction n (%) n (%) Placebo-adjusted (%) Peripheral edema 14 (11) 45 (17) 6 Nasal congestion 2 (2) 15 (6) 4 Sinusitis 0 (0) 8 (3) 3 Flushing 1 (1) 10 (4) 3 Most adverse drug reactions were mild to moderate and only nasal congestion was dose dependent. Few notable differences in the incidence of adverse reactions were observed for patients by age or sex. Peripheral edema was similar in younger patients (<65 years) receiving Letairis (14%; 29/205) or placebo (13%; 13/104), and was greater in elderly patients (≥65 years) receiving Letairis (29%; 16/56) compared to placebo (4%; 1/28). The results of such subgroup analyses must be interpreted cautiously. The incidence of treatment discontinuations due to adverse events other than those related to PAH during the clinical trials in patients with PAH was similar for Letairis (2%; 5/261 patients) and placebo (2%; 3/132 patients). The incidence of patients with serious adverse events other than those related to PAH during the clinical trials in patients with PAH was similar for placebo (7%; 9/132 patients) and for Letairis (5%; 13/261 patients). During 12-week controlled clinical trials, the incidence of aminotransferase elevations >3x upper limit of normal (ULN) were 0% on Letairis and 2.3% on placebo. In practice, cases of hepatic injury should be carefully evaluated for cause. Use in Combination with Tadalafil: The mean exposure to Letairis + tadalafil in the AMBITION study was 78.7 weeks. The adverse reactions that occurred in >5% more patients receiving Letairis + tadalafil than receiving Letairis or tadalafil monotherapy in AMBITION are shown in Table 2.

Table 2 Adverse Reactions Reported More Commonly (>5%) on Letairis + Tadalafil than on Letairis or Tadalafil Monotherapy in AMBITION Letairis + Tadalafil Letairis Tadalafil Combination Therapy Monotherapy Monotherapy (N=302) (N=152) (N=151) Adverse Reactions n (%) n (%) n (%) Peripheral edema 135 (45) 58 (38) 43 (28) Headache 125 (41) 51 (34) 53 (35) Nasal congestion 58 (19) 25 (16) 17 (11) 20 (13) Cough 53 (18) 24 (16) 11 (7) Anemia 44 (15) 17 (11) 5 (3) Dyspepsia 32 (11) 18 (12) 6 (4) Bronchitis 31 (10) 13 (9) Peripheral edema was more frequent on combination therapy; however, there was no notable difference observed in the incidence of peripheral edema in elderly patients (≥65 years, 37%) versus younger patients (<65 years, 39%) on combination therapy or Letairis monotherapy in AMBITION. Treatment discontinuations due to adverse events while on randomized treatment were similar across treatment groups: 16% for Letairis + tadalafil, 14% for Letairis alone, and 13% for tadalafil alone.

Use in Patients with Prior ERA Related Serum Liver Enzyme Abnormalities: In an uncontrolled, openlabel study, 36 patients who had previously discontinued ERAs (bosentan, an investigational drug, or both) due to aminotransferase elevations >3x ULN were treated with Letairis. Prior elevations were predominantly moderate, with 64% of the ALT elevations <5x ULN, but 9 patients had elevations >8 x ULN. Eight patients had been re-challenged with bosentan and/or the investigational ERA and all eight had a recurrence of aminotransferase abnormalities that required discontinuation of ERA therapy. All patients had to have normal aminotransferase levels on entry to this study. Twenty-five of the 36 patients were also receiving prostanoid and/or phosphodiesterase type 5 (PDE5) inhibitor therapy. Two patients discontinued early (including one of the patients with a prior 8x ULN elevation). Of the remaining 34 patients, one patient experienced a mild aminotransferase elevation at 12 weeks on Letairis 5 mg that resolved with decreasing the dosage to 2.5 mg, and that did not recur with later escalations to 10 mg. With a median follow up of 13 months and with 50% of patients increasing the dose of Letairis to 10 mg, no patients were discontinued for aminotransferase elevations. While the uncontrolled study design does not provide information about what would have occurred with readministration of previously used ERAs or show that Letairis led to fewer aminotransferase elevations than would have been seen with those drugs, the study indicates that Letairis may be tried in patients who have experienced asymptomatic aminotransferase elevations on other ERAs after aminotransferase levels have returned to normal.

Consult the full Prescribing Information for additional information regarding adverse reactions, including postmarketing events.

DRUG INTERACTIONS: Multiple dose coadministration of ambrisentan and cyclosporine resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers; therefore, limit the dose of ambrisentan to 5 mg once daily when co-administered with cyclosporine.

USE IN SPECIFIC POPULATIONS: Pregnancy Category X: Risk Summary: Letairis may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. Letairis was teratogenic in rats and rabbits at doses which resulted in exposures of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to a fetus [see Contraindications, Warnings and Precautions]. Animal Data: Letairis was teratogenic at oral doses of ≥15 mg/kg/day (AUC 51.7 h•μg/mL) in rats and ≥7 mg/kg/day (24.7 h•μg/mL) in rabbits; it was not studied at lower doses. These doses are of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day (14.8 h•μg/mL) based on AUC. In both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. A preclinical study in rats has shown decreased survival of newborn pups (mid and high doses) and effects on testicle size and fertility of pups (high dose) following maternal treatment with ambrisentan from late gestation through weaning. Doses tested were 17x, 51x, and 170x (on a mg/m2 body surface area basis) the maximum oral human dose of 10 mg and an average adult body weight of 70 kg. These effects were absent at a maternal dosage of 17x the human dose based on mg/m2. Nursing Mothers: It is not known whether ambrisentan is present in human milk.

Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Letairis, a decision should be made whether to discontinue nursing or discontinue Letairis, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Letairis in pediatric patients have not been established. Geriatric Use: In the two placebo-controlled clinical studies of Continued on next page

MARKETING YOUR PRACTICE Letairis (ambrisentan) tablets, for oral use Brief summary of full Prescribing Information (continued).

See full Prescribing Information. Rx only.

Letairis, 21% of patients were ≥65 years old and 5% were ≥75 years old. The elderly (age ≥65 years) showed less improvement in walk distances with Letairis than younger patients did, but the results of such subgroup analyses must be interpreted cautiously. Peripheral edema was more common in the elderly than in younger patients. Females and Males of Reproductive Potential: Pregnancy Testing: Female patients of reproductive potential must have a negative pregnancy test prior to initiation of treatment, monthly pregnancy test during treatment, and one month after stopping treatment with Letairis. Advise patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant. Perform a pregnancy test if pregnancy is suspected for any reason. For positive pregnancy tests, counsel patient on the potential risk to the fetus and patient options [see BOXED WARNING and Dosage and Administration]. Contraception: Female patients of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after stopping treatment with Letairis. Patients may choose one highly effective form of contraception (intrauterine device (IUD), contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). If a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. Counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see BOXED WARNING]. Infertility: Males In a 6-month study of another ERA, bosentan, 25 male patients with WHO functional class III and IV PAH and normal baseline sperm count were evaluated for effects on testicular function. There was a decline in sperm count of at least 50% in 25% of the patients after 3 or 6 months of treatment with bosentan. One patient developed marked oligospermia at 3 months and the sperm count remained low with 2 follow-up measurements over the subsequent 6 weeks. Bosentan was discontinued and after 2 months the sperm count had returned to baseline levels. In 22 patients who completed 6 months of treatment, sperm count remained within the normal range and no changes in sperm morphology, sperm motility, or hormone levels were observed. Based on these findings and preclinical data from ERAs, it cannot be excluded that ERAs such as Letairis have an adverse effect on spermatogenesis. Counsel patients about the potential effects on fertility [see Warnings and Precautions].

Renal Impairment: The impact of renal impairment on the pharmacokinetics of ambrisentan has been examined using a population pharmacokinetic approach in PAH patients with creatinine clearances ranging between 20 and 150 mL/min. There was no significant impact of mild or moderate renal impairment on exposure to ambrisentan. Dose adjustment of Letairis in patients with mild or moderate renal impairment is therefore not required. There is no information on the exposure to ambrisentan in patients with severe renal impairment. The impact of hemodialysis on the disposition of ambrisentan has not been investigated. Hepatic Impairment: Pre-existing hepatic impairment: The influence of pre-existing hepatic impairment on the pharmacokinetics of ambrisentan has not been evaluated. Because there is in vitro and in vivo evidence of significant metabolic and biliary contribution to the elimination of ambrisentan, hepatic impairment would be expected to have significant effects on the pharmacokinetics of ambrisentan. Letairis is not recommended in patients with moderate or severe hepatic impairment. There is no information on the use of Letairis in patients with mild pre-existing impaired liver function; however, exposure to ambrisentan may be increased in these patients. Elevation of Liver Transaminases: Other ERAs have been associated with aminotransferase (AST, ALT) elevations, hepatotoxicity, and cases of liver failure [see Adverse Reactions]. In patients who develop hepatic impairment after Letairis initiation, the cause of liver injury should be fully investigated. Discontinue Letairis if aminotransferase elevations >5x ULN or if elevations are accompanied by bilirubin >2x ULN, or by signs or symptoms of liver dysfunction and other causes are excluded.

OVERDOSAGE: There is no experience with overdosage of Letairis. The highest single dose of Letairis administered to healthy volunteers was 100 mg and the highest daily dose administered to patients with PAH was 10 mg once daily. In healthy volunteers, single doses of 50 mg and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea, and nasal congestion. Massive overdosage could potentially result in hypotension that may require intervention.

GS22-081-015 October 2015

Proven Strategies to Get Patients to Use Your Patient Portal

By Jennifer Thompson You need patients to use your patient portal, right? So, how can you get them on board to meet meaningful use requirements without creating a lot of work for you and your staff?

To help patients use your patient portal, here’s a few tips and strategies we’ve used with clients to get patients engaged and signed up.

UNDERSTAND BEHAVIOR AND DEMOGRAPHICS Instead of just creating a blanket statement and telling patients to use your patient portal, consider who your patients are and why they would want to use it in the first place. In other words, you’ll want to make a case that appeals to them specifically.

For patients with chronic conditions, promote the fact the portal offers: • Lab results • Vitals tracking • Care plans • Communication with a coach or provider For healthy patients, promote the fact the portal offers: • Appointment scheduling • Wellness resources (health tips, HRA assessments, etc.)

• Diet/exercise management • Communication with a coach or provider Diving into the demographics of your office can help create a plan that works for all of your patients. Plus, odds are you’ll find some valuable information about age, income, location, etc. that can be used for other areas of marketing your practice. Win-win.

CREATE A MARKETING PLAN How do you tell patients to use your patient portal? Is it just a sheet of paper you hand them before they leave? Is it a reminder email? You’ll want to tell them in as many ways as you can; so, although these are good ways to spread the word about your patient portal, they’re not enough. In addition to the methods mentioned above, consider:

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Letairis, the Letairis logo, GILEAD and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

Other brands noted herein are the property of their respective owners.

FLORIDA MD - APRIL 2016 15

MARKETING YOUR PRACTICE • • • •

Creating an eye-catching graphic you can use on your social media channels Using the same graphic to create a flyer / poster you can put around your office and in exam rooms so patients see it everywhere Use giveaways and promotional products with reminders if you have the budget Put a table in your lobby with material for patients to take home (this may sound silly, but they will be drawn to whatever is on the table - this is valuable real estate!)

PUT IT ON YOUR WEBSITE This is kind of a no-brainer, but you’ll want to add a link or button for patients to use your patient portal on your website. Make sure the link / button is easily visible and accessible on all pages of your website. We suggest keeping it out of your main navigation menu (because that’s probably crowded enough) and adding it to the header (top) section of your website. This way it’s easy to find, identify and click.

INCLUDE ENROLLMENT AS PART OF REGISTRATION Again, this is kind of a no-brainer, right? When patients are filling out their intake paperwork, make sure you collect email addresses and have a form or flyer ready to hand out.

We also suggest having a front desk “champion” that understands the patient portal like the back of her hand.

This way, whenever a patient is having trouble signing up or has a question, there is a designated resource person for them to go Serving Central Florida Since 1982 to. This may also help ensure continued use of the portal if she “checks in” on patients Our physicians are Board Certified in Internal Medicine, occasionally to make sure they’re using the Pulmonary Disease, Critical Care Medicine, and Sleep Medicine portal as they should.

Central Florida Pulmonary Group, P.A.

Specializing in: • • • • • • • • • •

Asthma/COPD Sleep Disorders Pulmonary Hypertension Pulmonary Fibrosis Shortness of Breath Cough Lung Cancer Lung Nodules Low Dose CT - On Site Clinical Research

Daniel Haim, M.D., F.C.C.P. Daniel T. Layish, M.D., F.A.C.P., F.C.C.P. Francisco J. Calimano, M.D., F.C.C.P. Francisco J. Remy, M.D., F.C.C.P. Ahmed Masood, M.D., F.C.C.P. Syed Mobin, M.D., F.C.C.P. Eugene Go, M.D., F.C.C.P. Mahmood Ali, M.D., F.C.C.P. Steven Vu, M.D., F.C.C.P. Ruel B. Garcia, M.D., F.C.C.P. Tabarak Qureshi, M.D., F.C.C.P. Kevin De Boer, D.O., F.C.C.P. Jorge E. Guerrero, M.D., F.C.C.P. Roberto Santos, M.D., F.C.C.P. Hadi Chohan, M.D. Jean Go, M.D. Guillermo Arias, M.D. Erick Lu, D.O. Downtown Orlando East Orlando Altamonte Springs 1115 East Ridgewood Street 10916 Dylan Loren Circle 610 Jasmine Road 407.841.1100 | www.cfpulmonary.com | Most Insurance Plans Accepted

16 FLORIDA MD - APRIL 2016

ENCOURAGE PROVIDERS TO PROMOTE THE PORTAL Your patients are a captive audience that listen to your doctors, right? In a perfect world they listen anyway - but we digress.

By having providers promote the portal, the idea is that adoption rates will go up because they’re being told by their doctor.

To help, provide training and incentives for providers to connect with patients using the portal. Make sure providers acknowledge when patients use the portal, or continue to use it.

Consider creating a canned phrase your providers can use to encourage continued use when they see a patient has used the portal. Something as simple as “Thank you for using our portal; we can really see your health matters to you.”

Jennifer Thompson is co-founder and chief strategist for DrMarketingTips. com, a website designed to help medical marketing professionals market their practice easier, faster and better. 

Check out our website – www.floridamd.com!

SPECIAL FEATURE

ORTHOPAEDIC UPDATE

Lawrence S. Halperin, M.D., Named Chair of the American Academy of Orthopaedic Surgeons Board of Councilors By Corey Gehrold Orlando-area orthopaedic surgeon Lawrence S. Halperin, M.D., became chair of the American Academy of Orthopaedic Surgeons (AAOS) Board of Councilors (BOC) at the organization’s 2016 Annual Meeting in early March.

The BOC consists of more than 100 members elected by state and regional orthopaedic societies and also represents Puerto Rico, the U.S. military, Canada, and four regional societies. The Board serves as an advisory body to the AAOS Board of Directors and committees. The BOC also manages the Academy’s relations with state and regional orthopaedic societies and conducts a wide range of programs to strengthen and support the societies.

“I have immensely enjoyed working with other orthopaedic surgeons from every corner of the United States. The BOC’s goal is to ensure the healthcare system functions well so we can deliver quality medical care to our patients,” says Dr. Halperin. “It is rewarding to feel I have made a small, yet positive impact on the system and I look forward to what we will be able to accomplish in the future.”

at Tulane University in New Orleans and a medical degree at the State University of New York (SUNY) Downstate Medical Center. Dr. Halperin completed an internship in general surgery and a residency in orthopaedic surgery at the SUNY Lawrence S. Halperin, Health Science Center and Kings MD County Hospital Center in Brooklyn. He also completed a fellowship in hand and upper extremity surgery with the Department of Orthopaedic Surgery at the SUNY Upstate Medical Center (formerly the SUNY Health Sciences Center) in Syracuse, N.Y. Dr. Halperin previously served as chair of the Academy’s Advocacy Resource Committee and was a part of the BOC for four years before his election into their leadership line. He also serves on the boards of directors of the Florida Orthopaedic Society and the Orange County Medical Society. 

The AAOS provides education and practice management services for orthopaedic surgeons and allied health professionals while also serving as an advocate for improved patient care and informing the public about the science of orthopaedics. Founded at Northwestern University as a not-for-profit organization in 1933, the AAOS has grown from a small organization serving less than 500 members to the world’s largest medical association of musculoskeletal specialists serving more than 39,000 members worldwide.

Members of the AAOS, called Fellows, are orthopaedists concerned with the diagnosis, care, and treatment of musculoskeletal disorders. The orthopaedist’s scope of practice includes disorders of the body’s bones, joints, ligaments, muscles, and tendons. Fellows have completed four years of medical school and at least five years of an approved “residency” in orthopaedics. In addition, they must pass a comprehensive oral and written examination, be certified by the AAOS, and submit to stringent membership review processes prior to admittance to the group.

Dr. Halperin specializes in hand, elbow and shoulder surgery at the Orlando Orthopaedic Center. He earned a Bachelor of Science degree in biological chemistry FLORIDA MD - APRIL 2016 17

CANCER

Transforming the Lives of Head & Neck Cancer Patients with Facial Prosthetics

By Elizabeth Feldman, MS, DMD, MS Head and neck cancer is among the most debilitating forms of cancer.

The disease comprises only three percent of all cancers in the U.S., but this figure doesn’t even begin to capture the far-reaching impact this cancer has on patients.

As a maxillofacial prosthodontist, a portion of my work is to give patients some semblance of normalcy after they’ve experienced a deformity of their face due to cancer resection. Patients may need a new nose, eye, ear, teeth or may need to replace part of their palate or tongue after surgery. My goal is to create a prosthesis for them that looks as realistic as possible, but more importantly, something that helps them feel comfortable in their daily lives. Providing function is also important for quality of life.

PROSTHETIC DEVICES FOR HEAD & NECK CANCER PATIENTS I’m often the last stop for patients after they see a head and neck surgeon and plastic surgeon. At UF Health Cancer Center – Orlando Health, I’m fortunate to work with a multidisciplinary team of skilled surgeons and clinicians.

I work closely with the head and neck surgeon and plastic surgeon and we usually are all in the operating room together. This way we can make a decision if a prosthesis should be made when the defect can’t be reconstructed by the plastic and reconstructive team. Working with my colleagues, we first decide whether we can place any craniofacial implant, which will be positioned around the resection site. Most patients are candidates for craniofacial implants. They are placed after the cancer resection surgery.

Patients may receive radiation treatment postoperatively. Once they are healed from radiation treatment, they come back to my team and we make a moulage of the defect area and then proceed with making a silicone prosthesis. The process is a bit complex: we first have to carve the material and create the structure, then have the patient fitted and ensure he or she is satisfied with what it looks like. We then process the silicone and use magnet attachments which may have to be customized to attach it to the defect area. This ensures the prosthesis is secure and that patients can perform everyday activities without fear that the device isn’t properly attached. The alternative to craniofacial implants is facial adhesive, which does not have a predictable retention mechanism.

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ORTHOPAEDIC SUBSPECIALTIES • SPINE • ELBOW • FOOT & ANKLE • HAND & WRIST • HIP • KNEE • ONCOLOGY • PEDIATRICS • SHOULDER • SPORTS MEDICINE • PAIN MANAGEMENT • PHYSICAL THERAPY

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GIVING HOPE TO PATIENTS Beginning with the consultation, the entire cancer journey is very emotional for my patients.

When you are diagnosed with cancer, and are faced with losing a part of yourself, it’s extremely difficult. Based on my experience, I can foresee what the patients will go through during their journey. I’m always very honest about what we can and cannot do for them and I take time to explain every step of the process, so they are completely comfortable. In most cases, I let them know that they will have something to replace the missing part.

Head and neck cancer can be debilitating because when you go out in public, the first thing people see is your face. Not to mention that losing a part of your body — like an ear or eye or nose — affects a person’s quality of life.

A prosthesis is an option for many patients and they all have the ability to decide whether they want this treatment. For most patients, the answer is yes. They want to feel

CANCER whole and want to feel that they won’t be ridiculed in public and that they can face their loved ones. In my seven years working as a maxillofacial prosthodontist at Orlando Health, I’ve never once had a patient refuse a facial prosthesis — this speaks to how important it is for them to feel like the person they were before their cancer diagnosis.

Every patient is unique. I’ve been fortunate and privileged to be able to help and to be part of my patient’s care — some who had head and neck cancer and others who were born with a defect. One such patient underwent 70 surgeries to reconstruct her eye and had a previous prosthetic that wasn’t secure enough and had fallen out during a dinner. She was referred to our team and we placed a craniofacial implant and reconstructed with a prosthetic eye. The device improved her ability to do ordinary (and not-so-ordinary) things — she even went on a roller coaster with her daughter feeling confident that her prosthesis would be retentive.

A prosthesis is life-changing for my patients, but it’s also important to note that these devices require ongoing follow-ups with a doctor for the rest of a patient’s life. I advise patients to get a new device every year, because as wounds heal we need a new moulage of the defect area so that the prosthesis fits better. Since the prosthesis is made with silicone, it also discolors over time, so patients may need a replacement.

Yearly follow-ups are a small investment compared to the significant impact a prosthesis has on someone’s everyday life. In the future, 3D bioprinting technology will help us create the prosthesis faster. This technology, along with intricate hand skills, will allow us to continue making prosthetic devices that are very life-like and enable patients to look and feel as normal as possible.

I’m proud that what we do shows patients who have survived head and neck cancer that there’s always an option — even when they think there are none.

Elizabeth Feldman, MS, DMD, MS, leads the Dental Section as part of the Thoracic/Head and Neck Cancers Specialty Section at UF Health Cancer Center – Orlando Health where she provides maxillofacial prosthodontics and dental oncology services.

Dr. Feldman received a master’s degree in medical radiation physics from Chicago Medical School, and then went on to earn her dental degree from Nova Southeastern University (NSU). She completed her specialty training in prosthodontics at the University of Florida where she also earned a master’s degree in science. She completed her fellowship training in maxillofacial prosthodontics and oncologic dentistry at The University of Texas MD Anderson Cancer Center in Houston.

Dr. Feldman focuses on prosthetic correction and management of patients with maxillofacial rehabilitation needs, especially head and neck cancer patients. She is trained to make intraoral and extraoral prostheses. Her special interests include orofacial implant rehabilitation as well as taking care of patients with bisphosphonate and radiation osteonecrosis, chemotherapy and radiation therapy effects on the oral cavity. She has extensive experience with traumatic injuries – and children with special needs, including ectodermal dysplasia.

Dr. Feldman received the 2009 Distinguished Alumni Award from the NSU College of Dental Medicine. She is a fellow of the American Association of Maxillofacial Prosthetics, a member of the American College of Prosthodontics, NSU College of Dental Medicine, American Dental Association, Academy of Osseointegration and a fellow of the International Congress of Oral Implantologists. She is also fluent in Russian. 

FLORIDA MD - APRIL 2016 19

DIGESTIVE AND LIVER UPDATE

Choledocholithiasis

By Srinivas Seela, MD Choledocholithiasis is the presence of at least one gallstone in the common bile duct. The stone may be made up of bile pigments or calcium and cholesterol salts. Gallstones usually form in your gallbladder. The gallbladder is a pear-shaped organ below your liver in the upper-right side of your abdomen. These stones usually remain in the gallbladder or pass through the common bile duct unobstructed. The bile duct is the small tube that carries bile from the gallbladder to the intestine. According to research published in the Medical Clinics of North America, approximately 15 percent of people who have gallstones develop choledocholithiasis. Of that 15 percent, an estimated five percent to 12 percent have primary bile duct stones.

CAUSES About 1 in 7 people with gallstones will develop stones in the common bile duct.

Risk factors include a history of gallstones. However, choledocholithiasis can occur in people who have had their gallbladder removed.

Gallstones often pass through the common bile duct unnoticed. However, about 15 percent of all people with gallstones will have gallstones in the bile duct.

There are two types of gallstones: cholesterol stones and pigment stones.

Scientists believe that cholesterol stones are caused by bile that contains: • Too much cholesterol • Too much bilirubin • Not enough bile salts • They may also occur if the gallbladder does not empty completely or often enough.

The cause of pigment stones is not known. They seem to occur in people who have: • Cirrhosis of the liver • Biliary tract infections • Hereditary blood disorders in which the liver makes too much bilirubin

SYMPTOMS Often, there are no symptoms unless the stone blocks the common bile duct. Symptoms may include: • Pain in the right upper or middle upper abdomen for at least 30 minutes. The pain may be constant or cramping. It can feel sharp or dull.

• Fever • Yellowing of skin and whites of the eyes (jaundice) • Loss of appetite • Nausea and vomiting • Clay-colored stools Physical examination — On physical examination, patients 20 FLORIDA MD - APRIL 2016

with choledocholithiasis often have right upper quadrant or epigastric tenderness.

Patients may also appear jaundiced. Courvoisier’s sign (a palpable gallbladder on physical examination) may be seen when gallbladder dilation develops because of an obstruction of the common bile duct. It is more often associated with malignant common bile duct obstruction, but has been reported with choledocholithiasis

DIAGNOSIS AND INVESTIGATIONS • • • • • • • • •

Abdominal CT scan Abdominal ultrasound Endoscopic retrograde cholangiography (ERCP) Endoscopic ultrasound Magnetic resonance cholangiopancreatography (MRCP) Labs: Bilirubin Complete blood count (CBC) Liver function tests Pancreatic enzymes

WHO IS AT RISK FOR CHOLEDOCHOLITHIASIS? People with a history of gallstones or gallbladder disease are at risk for bile duct stones. Even people who have had their gallbladders removed can experience this condition.

Some of the risk factors for gallstones can be improved through lifestyle changes. The following increase your chances of developing gallstones: • Obesity • Low-fiber, high-calorie, high-fat diet • Pregnancy • Prolonged fasting • Rapid weight loss • Lack of physical activity Risk factors you cannot change include: • Age: older adults typically have a higher risk for gallstones • Gender: women are more likely to have gallstones • Ethnicity: American Indians and Mexican-Americans are at higher risk for gallstones. Gallstones in the bile duct are more common in Asian populations • Family history: genetics may play a role • Gallstones in the bile duct may not cause symptoms for months or even years. However, if the blockage becomes severe, you may experience the following: • Abdominal pain in the upper or middle-upper abdomen • Fever • Jaundice (yellowing of the skin and eyes) • Loss of appetite • Nausea and vomiting When a gallstone is stuck in the bile duct, the bile can become infected. The bacteria from the infection can spread rapidly. It

DIGESTIVE AND LIVER UPDATE can move into the ductal system and then into the liver. It can become a life-threatening infection.

Please seek medical attention immediately if any of the following are witnessed

The pain caused by gallstones in the bile duct can be sporadic, or it can linger. The pain may also be mild at times and then suddenly severe. Severe pain may require emergency medical treatment. (The most severe symptoms are commonly confused with a cardiac event.)

• You develop abdominal pain, with or without fever, and there is no known cause.

TREATMENT The goal of treatment is to relieve the blockage.

•

You develop jaundice.

•

You have other symptoms of choledocholithiasis.

•

Alternative Names

•

Gallstone in the bile duct; Bile duct stone

Treatment may involve: • Surgery to remove the gallbladder and stones • ERCP and a procedure called a sphincterotomy, which makes a surgical cut into the muscle in the common bile duct to allow stones to pass or be removed • Stone extraction • Fragmenting stones (lithotripsy) • Surgery to remove the gallbladder and stones (cholecystectomy) • Surgery that makes a cut into the common bile duct to remove stones or help them pass (sphincterotomy) • Biliary stenting • The most common treatment for gallstones in the bile duct is biliary endoscopic sphincterotomy (BES). During a BES procedure, a balloon- or basket-type device is inserted into the bile duct and used to extract the stone or stones. About 85 percent of bile duct stones can be removed with BES. If a stone does not pass on its own or cannot be removed with BES, doctors may use lithotripsy. This procedure is designed to fragment stones so they can be captured or passed easily.

Patients with gallstones in the bile duct and gallstones still in the gallbladder may be treated with cholecystectomy (gallbladder removal). While performing the surgery, your doctor will also inspect your bile duct to check for remaining gallstones.

If stones cannot be removed completely or you have a history of gallstones causing problems but do not wish to have your gallbladder removed, your doctor may place biliary stents (tiny tubes to open the passage). These will provide adequate drainage and help prevent future choledocholithiasis episodes. The stents can also prevent biliary sepsis (inflammation) and infection.

OUTLOOK (PROGNOSIS) Blockage and infection caused by stones in the biliary tract can be life threatening. Most of the time, the outcome is good if the problem is detected and treated early.

POSSIBLE COMPLICATIONS Complications may include: • Biliary cirrhosis • Cholangitis • Pancreatitis

Srinivas Seela, MD moved to Orlando, Florida after finishing his fellowship in Gastroenterology at Yale University School of Medicine, one of the finest programs in the country. During his training he spent a significant amount of time in basic and clinical research, and has published articles in Gastroenterology literature.

His interests include advanced and therapeutic endoscopic procedures, colorectal cancer screening, Gastro Esophageal Reflux Disease (GERD), metabolic and other liver disorders.

Dr. Seela is board certified in both Internal Medicine and Gastroenterology. He is a member of the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), the American Association for the Study of Liver Diseases (AASLD), and Crohn’s Colitis Foundation (CCF).

In addition to being an Assistant Professor at the University of Central Florida School of Medicine, he is also a teaching attending physician at both the Florida Hospital Internal Medicine Residency and Family Practice Residence (MD and DO) programs. Dr. Srinivas Seela is a gastroenterologist at Digestive and Liver Center of Florida.

Contact information 407-384-7388.



FLORIDA MD - APRIL 2016 21

BEHAVIORAL HEALTH

Understanding the Legality of Involuntary Hospital Commitment

By Sajid Hafeez, MD Unlike many medical fields, mental health has perhaps the strangest relationship with its patients in that it frequently administers services to patients who many times do not desire them. This prospect is something that can be quite disconcerting to the patients and their loved ones. This is also something that may not be completely understood by the practitioners of other medical disciplines. So to those ends, it’s helpful to have an understanding of the true nature of involuntary commitment, the legality of it, and what it means to the patient and practitioner.

Most states have allowed for a legality of sorts that allows for trained individuals to act in what they feel is in the best interest of a person who is not of sound mind. In Florida, the ruling law of this is the Baker Act, the common name for the Florida Mental Health Act of 1971. The Act allows for the immediate detainment of any individual Danna-Gracey Lead Agent, Orlando Office who is deemed to be of imminent risk of Danna-Gracey Lead Agent, Orlando Office harm to self or others and is deemed menDanna-Gracey is pleased to introduce Michelle Bilsky our newtally incompetent.

Frequently, at-risk individuals are idenest team member. Heading up our Orlando office, Michelle tified by police officers responding to calls brings over 26 years in the insurance industry to Danna-Gracey. who are trained to identify key criteria and transport the individual in question to the Michelle holds a Bachelor of Science degree from the nearest Baker Act receiving facility to be asUniversity of Central Florida and an Executive Leadership sessed by a doctor. The law also allows for Certificate from The Wharton School in Philadelphia, PA., as a physician, clinical social worker, mental health counselor, marriage and family therawell as certifications in behavior analysis, risk management, pist, or psychiatric nurse with a master’s deHIPAA and OSHA. Michelle is also a frequent and highly rated gree to Baker Act anyone that the feel meets speaker on industry related topics the criteria. Once a person is “Baker Acted,” and has been recognized and so long as that patient is cleared as medically approved to provide CME credits stable by a hospital, a person may be held involuntarily for 72 hours. (Similarly, a judge for her lectures. may order an ex-parte wherein a family may beseech the court to file involuntary comFor a no-obligation assessment of mitment based on testimony without the your current malpractice coverage, person in question present- hence the term or for more information on addiEx Parte, which means “derived from the tional coverages designed to proparty” in Latin. The only difference between this and the Baker Act is that an Ex Parte tect your practice, such as workers’ allows for a person to be held involuntarily compensation, cyber liability, medifor 7 days.) cal directorship, employment practicWhat confuses most is what happens es liability (EPLI), and investigatory once a patient is transferred to a psychiatric coverage, contact Michelle today hospital before the allowed time period has at 888.496.0059 or michelle@ expired. Under the law, a psychiatrist must examine this patient within 24 hours of ardannagracey.com to see what rival to the facility. The doctor then has the she can do for you. remaining time left in the Baker Act or Ex Parte to rule the patient as competent or incompetent. If the patient is found competent, he or she is given the opportunity to be transitioned to a Voluntary admission to the hospital where he or she is able to receive michelle@dannagracey.com • dannagracey.com doctor recommended treatment until the

Introducing Michelle Bilsky

888.496.0059

22 FLORIDA MD - APRIL 2016

BEHAVIORAL HEALTH doctor feels that the patient has reached maximum benefit from acute inpatient hospitalization and is stable enough to proceed to a step down into outpatient care. Or, if a patient (or parent) decides that he or she has no desire to pursue stabilization, that patient (or parent) may elect to discharge from the hospital. However, if the doctor feels the patient is competent, but still in need of inpatient care, the discharge may be against medical advice (AMA), which is a way for the doctor who protect himself from liability should the patient relapse.

However, if by the end of the allowed involuntary time period the doctor feels that the patient is not of sound mind and unable to make competent decisions, the doctor may initiate what is referred to as a “32.” This is a petition to extend the involuntary commitment.

When the petition is initiated, the allotted time period freezes. During this time, a second doctor is contacted to do an independent assessment. If the second doctor reaches the same conclusion that the person is not mentally competent, the petition is forwarded to the local court , which will arrange a hearing with a judge. At this hearing the doctor, patient, and or parents are given an opportunity to testify before the judge. If the judge believes the doctor’s assessment is correct, he will extend the length of time that a patient can be involuntarily held at the suggestion of the doctor with the intention to provide treatment for stabilization. At this time, if the patient lacks a parent or proxy to act as the decision maker in the best interest of the patient, the court will initial the process to provide a guardian ad litem decision maker. (This is necessary, as a person who is deemed to be incompetent cannot consent to treatment or medications and requires a proxy to act on his or her behalf.)

To those new to it, involuntary commitment can seem to be an overwhelming concept mired in a mire of uncertain legality. In reality, at its heart, it is a fairly straightforward set of rules developed to protect those whose unstable mental status leaves them vulnerable to a world that they are not, unfortunately, sound enough to understand. These laws provide the opportunity for the professionals to work toward returning these patients back to a place in life where they can once again make rational, thoughtful choices and work to improve the quality of their life.

Sajid Hafeez, M.D., is a child and adolescent psychiatrist who is serving as a Medical Director of the Acute Care Baker Act Unit at the University Behavioral Center. He also served as the Center’s Medical Director of the long term Residential Units: ASAPP Unit (for adolescent boys with inappropriate sexual behaviors), Solutions Unit (for adolescent boys with behavior problems), Promises and Stars Unit (for adolescent females with behavioral problems as well as victims of sexual abuse), and Discovery Unit (for children ages 5-13 with behavioral as well as inappropriate sexual problems). In addition, Dr. Hafeez also Served as an Assistant Professor of Psychiatry at the University of Central Florida (Voluntary Position). He was also the Chief of the Adolescent Psychiatry Unit, an Attending Psychiatrist of the Comprehensive PsychiaOften times the stress of everyday life can be overwhelming. A particutry Emergency Program and of the larly traumatic event can change your life in an instant. We are here.

Mobile Crisis Team at the Westchester Let us help you navigate through life’s sometimes unpredictable turns.

Medical College. At Vassar Brother’s UBC is a 112 bed psychiatric inpatient and substance abuse/detox hosMedical Center in New York. Dr. pital. UBC offers children, adolescents, and adult programs and accepts Hafeez was the Director of Outpamost insurances including Medicare and Tricare. We offer specialized tient Child & Adolescent and Adult treatment based on the individual and treat the following common diPsychiatric Clinic as well as Director agnoses as well as others: of Consultation and Liaison PsychiaPLEASE PLACE STAMP HERE

try. Dr. Hafeez received his adult Psychiatry and Residency Training at the University of Kansas Medical Center in Kansas City. He received his Child and Adolescent Psychiatry fellowship training at the New York Medical College New York and at Children’s National Medical Center of George Washington University in Washington, DC. Dr. Hafeez can be reached at 407-281-7000 or by visiting www. universitybehavioral.com. 

        

Anxiety/Phobias Depression Bi-polar Disorder Co-occurring Disorders Phobias Grief Adjustment Disorders Anger Management ADHD

 

  

Trauma Related Issues Substance Abuse Treatment (Adult) Detox services (Adult) Intensive Outpatient- Substance Abuse (Adults) Intensive Outpatient and Partial Hospitalization- Mental Health (Adults)

TO SCHEDULE A FREE AND CONFIDENTIAL ASSESSMENT CALL 407-281-7000 or FAX REFERRAL TO 407-282-5410 2500 Discovery Drive Orlando, FL FLORIDA MD - APRIL 2016 23

INPATIENT REHABILITATION

NDT/Bobath Approach: Enhanced Comprehensive Neurorehablition Services

By Kristy Bautista-Harris MS. OTR/L, CBIS, C/NDT Within my fourteen years of experience as an occupational therapist, I have specialized within the domain of neurorehabilitation becoming both NeuroDevelopmental Treatment (NDT) and Brain Injury Certified (CBIS). I have had the opportunity to work in many settings throughout the continuum of care including acute care, inpatient rehabilitation, skilled nursing and home health. I have had the pleasure of working with patients with a myriad of diagnoses including neurological, orthopedic and cardiac.

Specialization and intensive training within the Neurodevelopmental Treatment (NDT) approach has been pivotal for enhanced assessment and treatment of patients with neurological conditions such as traumatic brain injury and stroke. By using NDT based assessment and treatment approach, our team is able to further maximize not only motor control after neurological lesions, but also functional independence in areas such as Activity of Daily Living and Instrumental Activities of Daily Living and help patients return to work, school and their community.

Question 1-What is the NDT certification?

NDT is a systematic approach to stroke and brain injury rehabilitation that focuses on improving posture and muscle tone through proper handling and facilitation of normal movement. The main principle of NDT is to “reduce muscle spasticity and promote normal patterns of movement” (Seneviratne and Reiner, 2004, p13).

Question 2-How is this method different from conventional Occupational therapy methods?

Occupational Therapy supports health and participation in life through engagement in occupation (AOTA 2008). This correlates with the NDT approach to restore movement patterns which results in an increased participation in our patients’ occupations. The NDT approach is incorporated throughout the evaluation, constant assessment and treatment to facilitate motor control and functional movement. NDT also teaches the delayed use of adaptive equipment to “fix” the problem versus aligning, handling, and facilitating movement to give the body from freedom to re-learn movement without being constrained with a sling or any orthotic. Reviews of research about Bobath (NDT) Therapy have shown that receiving NDT or a combination of NDT and other intervention led to better performance and immediate increase in range of movement (Butler and Darrah, 2001, DeGangi, 1994).

Questions 3-What are the benefits for someone who has had either a stroke of traumatic brain injury? NDT is not a specific technique but an overall philosophy that uses the knowledge of typical and atypical development and motor patterns, functional task analysis, motor control and motor learning to develop appropriate, individualized treatment plans including: • Improved gross motor function, self care skills and reduced caregiver assistance (Knox and Lloyd-Evans, 2002, DeGangi, 1994) • Increased range of movement (Butler and Darrah, 2001, DeGangi, 1994) • Progression of supported walking demonstrated by improved stride length, range of movement, strength, step length, heel contact, velocity of walking and reduced spasticity (Desloovere et al., 2012) (Adams et al., 2000, Embray et al., 1990) • Advanced motor progress has been shown to occur after more intense NDT is delivered in a block (Tsorlakis et al., 2004, Mayo, 1991, Trahan and Malouin, 2002) • Improved reaching, hand opening and hand use (Jonnsdottir et al., 1997, Kluzik et al., 1990, Chakarian and Larson, 1993).

Seeing a patient that couldn’t sit at the edge of a bed walk more than 300 feet with a walker truly shows the benefits of NDT and how it can change the lives of my patients. In therapy, “therapists must give LIFE, not exercise” (Bobath, 1984) Kristy Bautista-Harris MS. OTR/L, CBIS, C/NDT, is Senior Occupational Therapist at HealthSouth Rehabilitation Hospital of Altamonte Springs. Kristy graduated from Barry University with a Bachelor of Health Administration degree and went on to complete a Master’s of Science in Occupational Therapy degree at Barry University in Miami. She has 14 years of experience as a Occupational Therapist. Kristy has been with HealthSouth of Altamonte Springs since the hospitals opening in October 2014. Kristy is fluent in Spanish. . 

24 FLORIDA MD - APRIL 2016

Medical Office Resources of Florida is MORe OF what Healthcare Needs

By Dorothy Mowbray, M.O.R.O.F. Media Committee Chair and Board Member As doctors, you take care of your patients. As MOROF, we help take care of your practice whether you are starting a new one, maintaining or planning for growth and expansion. Here’s how MOROF has impacted some of our members at all stages of their medical business.

Dr. Pamela Trout recently started her own pediatric practice, Doc PAM in Winter Park and tells her story: Dr. Pamela Trout “Out of sheer luck, my new insurance agent (MOROF member Jeri Cascio) invited me as her guest to a MOROF monthly meeting. Immediately I was embraced by the organization, and once they knew I was a start-up doctor trying to open a new practice, the invites and offers started pouring in on how they could help me. And knowing sales people vs. people with good intentions (this is not my first rodeo), I knew these people genuinely had my best interest at heart. It was a much-needed support at a time when I was feeling the true consequences of being “on your own.”

MOROF has kept in touch with me, tracking my progress and trying to anticipate what help I may need next. In fact there may be a few members wearing t-shirts with my Doc PAM logo running around town helping to promote my new practice and increase awareness.

I have been to two MOROF meetings so far; one on ICD-10, which although painful, was so timely and well done. Not only this, but it was a room full of people who were trying to come up with how they can Blake Warren, help their doctors succeed in the transition. Awesome!

I was able to bring my office manager to another meeting on surviving social media in medicine. It was invaluable for me and for my staff. The presentations were practical, educational, backed by data... and most of all there were contacts right there to discuss any help we may need on launching a bigger social media presence.

In medicine, some of our societies are like a second family. I thought only physician societies would have members that understand the challenges we face every day. Instead I have found a new family that not only understands, but has a wide variety of professionals that not only can help but are also looking out for me!

Priceless.”

To maintain your practice, Celia Myres, Administrator for Excel Hospitalist Partners and past President of the CFMGMA claims “every office needs to keep up with the trends in best practices and the growing insurBob Nies ance, coding, compliance issues we face. MOROF provides experts to answer my questions and address my Winter Park Recovery fears.”

Another local healthcare veteran is Blake Warren, MHSA, Executive Director, Central Florida AHEC, Inc. “Since joining the M.O.R.O.F. organization, we’ve had the opportunity to interact and collaborate with new and like-minded organizations to better understand our healthcare environment and how we might better bring a multi-faceted, multi-disciplinary, integrated approach to better health and wellness” For practices in a growth stage, Bob Nies of Winter Park Recovery says “ MOROF has been extremely beneficial for our company as we pursue our growth plans. Among the specialists we have been able to interface has enabled us to solve many problems that confront all business entities. This is especially true with all the new compliance issues as a result of Obamacare, HIPPA, FIPA and ICD-10.

Monthly presentations and the web site are on target for medical practices to be in compliance with all the regulations now mandated, while offering network and landing page marketing opportunities.”

Celia Myres sums it up by saying “Every healthcare professional needs a network of engaged and concerned vendors and colleagues to navigate the challenging maze of managing a medical office. I find MOROf significantly augments my established network from years of experience and participation in the CFMGMA. In my role as Past President of that organization, I bristle from the comments from those that say they don’t have the time to engage with either or both organizations. As busy as I am, I save countless hours by accessing the people and information available through MOROF, and to be late one Thursday a month, by maybe an hour or two is a great investment with ample return. Plus, I often communicate with MOROF members in off-hours, through email or by accessing their website or LinkedIn discussions.”

MOROF meets the fourth Thursday of each month from 7:30 a.m. to 9 a.m. at the Venue On The Lake at the Maitland Civic Center. Address is 641 South Maitland Ave. Maitland, FL 32751. Healthcare professionals are always welcome as guests. RSVP at www.mor-of.net Also check out archived presentations, a member directory and more resources on this same website.  FLORIDA MD - APRIL 2016 25

Critical Condition: Doctor Groups Link Arms to Save Profession — Fed Up With Excessive Oversight, Doctors Get Organized – Part Two By Marni Jameson All across America a movement is afoot that is unlike any other. Doctors, fed up with the intrusion of government overreach and corporate acquisitions, are speaking out, and joining forces to protect their profession.

They have seen the writing: Doctors are in critical condition.

To survive, they are creating membership groups to fight the regulations that are crippling them and the pressure to succumb to employment.

Besides the Association of Independent Doctors, a trade association that started in Florida three years ago to enlighten consumers, businesses and lawmakers about the importance of supporting independent doctors, and that has grown like wildfire spreading coast to coast, here are a few other groups fighting for the cause.

Of note, all these groups are working together with AID:

ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS Although the Association of American Physicians and Surgeons has been around since 1943, lately it has taken a new tack. When I attended the AAPS annual meeting in January in Orlando, the day focused entirely on the topic of opting out of Medicare and Medicaid, and even from some insurance plans, so patients pay directly for services.

Dr. Elaina George, an Atlanta otolaryngologist, an AAPS leader and an active AID member, spoke at the meeting, and shared her partial direct pay model. Direct pay, she says, “is the future.”

Tired of the red tape, Dr. George, who has her own surgical center so can bypass the hospital, has opted out of Medicare, and out of contracts with “payors who give me nothing but administrative headaches and low reimbursements,” she said. “I got tired of playing how low can you go. When you cut out the middleman, it’s much more affordable for patients.”

AMERICAN COLLEGE OF PRIVATE PHYSICIANS While the AAPS helps liberate doctors from the tyranny of third-party payers, a new group, the American College of Private Physicians, helps them navigate the waters of direct practice or concierge medicine.

Two years ago, AID Executive Board Member Dr. Tom LaGrelius, a concierge physician practicing in Torrance, California, formed ACPA. “This group picks up where the AAPS leaves off, helping members navigate the day to day running of a concierge 26 FLORIDA MD - APRIL 2016

practice,” said Dr. LaGrelius, who estimates that 10,000 U.S. doctors are working this way in some fashion.

“We want to help doctors take back control,” he said.

LET MY DOCTOR PRACTICE Last year, Let My Doctor Practice formed under the direction of Dr. Mike Strickland, an Ohio internist. The group held a summit in Keystone, Colorado, where practitioners gathered to discuss strategies to oppose the constraints tying doctors’ hands.

“We believe in the sanctity of the doctor-patient relationship, and the autonomy to practice medicine without restraint imposed by overreaching government and corporate entities,” said Dr. Strickland. “Let My Doctor Practice is a movement to restore the voice of the doctor to the practice of medicine.”

That means working to stop the intrusion into the doctor-patient relationship by third parties, he said, “fighting ‘Meaningful Use,’ which is a degradation of the medical record, and not letting health insurers dictate care options over doctors’ recommendations.”

Remarkably, while associations in the same industry often compete for members, the opposite here is true. Rather than elbow each other out, we link arms.

I’ve been a guest on Dr. George’s radio show, “Medicine on Call.” I will deliver the opening address at the American College of Private Physicians annual meeting in Las Vegas this September.

And I sit on the advisory committee of Let My Doctor Practice.

“It’s simple,” said Dr. Strickland. “We all want to return the practice of medicine to those who actually practice medicine. We are sick of being told how to practice.”

Atlas is shrugging.

Marni Jameson is the executive director of the Association of Independent Doctors, a national nonprofit dedicated to helping reduce health-care costs by helping consumers, businesses and lawmakers understand the value of keeping America’s doctors independent www.aid-us.org. You may reach her at marni@aid-us.org. 

www.floridamd.com

The HIPAA Privacy Rule

by Michelle Bilsky The HIPAA Privacy Rule establishes a set of national standards for the use and disclosure of individually identifiable health information – often referred to as protected health information – by covered entities, as well as standards for providing individuals with privacy rights and helping individuals understand and control how their health information is used. HIPAA Privacy Rule requirements: • Apply to most health care providers, including those who do not have EHRs or do not participate in a CMS EHR incentive program; • Set a federal floor for protecting individually identifiable health information across all mediums (electronic, paper, and oral); • Limit how covered entities may use and disclose individually identifiable health information they receive or create; • Give individuals rights with respect to their protected health information, including a right to examine and obtain a copy of information in their medical records, and the right to ask covered entities to amend their medical record if information is inaccurate or incomplete; • Impose administrative requirements for covered entities, such as training of employees with regard to the Privacy Rule; and • Establish civil and criminal penalties.

Several central tenets of the Privacy Rule are: • In general, you may use or disclose protected health information for treatment, payment, and health care operations without obtaining a patient’s written permission. For other purposes, such as marketing, you may need to obtain an individual’s authorization to use or disclose the patient’s protected health information.

• Your agreements with business associates must explicitly require them to comply with HIPAA, including breach notification requirements.

carry out an action. This is called the “minimum necessary rule”. There are several exceptions to this rule. For example, generally, you do not have to limit the disclosure of protected health information to the minimum amount necessary when you are disclosing the information for treatment of the individual.

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• Generally, you and your business associates must limit your access to, use of, and disclosure of protected health information to the minimum necessary to FLORIDA MD - APRIL 2016 27

PATIENTS’ RIGHTS AND THE MEDICAL PRACTICE’S RESPONSIBILITIES Under HIPAA, patients have legal, individual rights to access their health information and learn about disclosures of their health information. As their health care provider, you are responsible for respecting these rights.

As a covered entity, you have responsibilities to patients under the HIPAA Privacy Rule, including: • Notice of Privacy Practices: Under the HIPAA Privacy Rule, covered entities must provide patients with full information on how their protected health information is used and disclosed. This is accomplished by giving patients a Notice of Privacy Practices that describes how an individual’s information may be used or shared, specifies an individual’s legal rights with respect to their protected health information held by the covered entity, and the covered entity’s legal duties.

• Patient access to their information: Patients have the right to inspect, review, and receive a copy of health information about themselves held by covered entities or business associates in a designated record set, which includes a health care provider’s medical and billing records. Generally, these health plans and providers have to comply with requests for access within 30 days.

• Amending patient information: Patients have the right to request that covered entities amend their protected health information in a designated record set when that information is inaccurate or incomplete. If a covered entity accepts an amendment request, it must make reasonable efforts to provide the amendments to persons identified by the individual as having received the original information and in need of the amendment(s) as well as those entities that the covered entity itself identified as having received the original information who would be in need of the amendments due to their prior or foreseeable reliance on the original information to the detriment of the individual. If the request is denied, covered entities must provide the individual with a written denial and allow the individual to submit a statement of disagreement for inclusion in the record.

• Accounting of disclosures: Individuals have a right to receive an accounting of disclosures, which is a listing of when a HIPAA covered entity has shared the individual’s PHI with a person or organization outside of the entity. Accounting is only required for certain disclosure purposes. A covered entity must provide an accounting of disclosures made during the accounting period, which is six years immediately preceding the accounting request, but a covered entity is not obligated to account for any disclosure made before its Privacy Rule compliance date.

• Rights to restrict information: Individuals have the right to request that a covered entity restrict use or disclosure of protected health information for treatment, payment or health care operations, disclosure to persons involved in the individual’s health care or payment for health care, or disclosure to notify family members or others about the individual’s general condition, location, or death. A covered

Patient Assistance Resources The CF Foundation is committed to improving the lives of all people and families with CF. We can help you with: •Insurance coverage and benefits •Resources to pay for therapies and medications •Legal information •Other concerns Tell us your issue.

We will help you find a solution.

888-315-4154 • parc@cff.org • www.cff.org

29 FLORIDA MD - APRIL 2016

entity is under no obligation to agree to requests for restrictions; however, a covered entity must have a procedure to evaluate all requests.

A covered entity that does agree must comply with the agreed restrictions, except for purposes of treating the individual in a medical emergency.

THE HIPAA SECURITY RULE The HIPAA Security Rule establishes national standards to protect individuals’ electronic protected health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information. The HIPAA Security Rule requires providers to implement security measures, which help protect patients’ privacy by creating the conditions for patient health information to be available, but not be improperly used or disclosed. These requirements apply only to e-PHI. All health care providers considered “Covered Entities” under HIPAA (most are) are responsible for complying with the two related rules of HIPAA: Privacy and Security. The HIPAA Security Rule sets out specific protections that all covered providers must follow to protect health information. These practices include administrative, technical, and physical safeguards. These safeguards, when applied well, can help practices avoid some of the common security gaps that lead to cyber-attack or data loss. They can protect the people, information, technology, and facilities that health care providers depend on to carry out their primary mission: helping their patients.

The HIPAA Security Rule requires three kinds of safeguards: administrative, physical, and technical.

Michelle Bilsky is a medical malpractice insurance specialist with Danna-Gracey. She can be reached at or (888) 496-0059 or Michelle@dannagracey.com.. 

COMING NEXT MONTH: The cover story focuses on Alexander Rosemurgy, MD and the Digestive Health Institute at Florida Hospital Tampa. Editorial focus is on Women’s Health and Advances in Cosmetic Surgery.

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The Florida Hospital Cancer Institute is proud to bring the highlights of the ASCO Annual Meeting to Orlando, Florida through its licensed Best of ASCO® meeting, to be held at the Hyatt Regency Grand Cypress, Orlando, Florida.

Florida Hospital is accredited by the Florida Medical Association to provide continuing medical education for physicians.

Florida Hospital designates this live activity for a maximum of 8 AMA PRA Category 1 Credit(s)™. Each physician should claim only those hours of credit commensurate with the extent of their participation in the activity.

Florida Hospital is committed to making its activities accessible to all individuals. If you have a disability, please submit a description of your needs, along with your registration, to assure that you will be able to participate in the activity.

ASCO is not the CME provider for this activity.

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